DOC-20017a EU MDR O2 Cannulas Dec of Conf Rev 1
DOC-20017a EU MDR O2 Cannulas Dec of Conf Rev 1
2797
DECLARATION OF CONFORMITY DOC-20017a Oxygen Cannulas
SRN: US-MF-000007934 Basic UDI: 006074TF1005_Cannulas27
Oxygen Cannulas A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils at flows 0 LPM to 6 LPM.
Product Name: Intended Purpose
See the following table Doc-20017a 12-Sept-2022
Model Number or Designator:
Control Designator: Device Classification:
Class IIa, Rule 2, according to the (EU) MDR 2017/745, Annex VIII, Chapter I short-term use; Chapter III, Rule 2 non/invasive channeling gases
Route of conformity is according to (EU) MDR 2017/45 Annex IX Quality Management System
Conformity Route:
R03010203 : air / oxygen nasal cannula 35201 basic nasal oxygen cannula
EMDN Nomenclature code (EMDN):
Global Medical Device Nomenclature Code (GMDN): Universal Medical Device Nomenclature System (UMDNS):
12799: Cannulae, Nasal oxygen
Product Options/Accessories:
N/A
EC Certificate – Full Quality Assurance System
MDR 738597
Notified Body:
BSI Group Inc., Notified Body CE 2797 Say Building John M. Keynesplein 9 1066 EP Amsterdam Netherlands www.bsigroup.com
Authorized EU Representative:
MT Promedt Consulting GmbH Ernst-Heckel-Straße 7 66386 St. Ingbert Germany
Revision: 1
Authorized Signature and Function Printed Name: Rob Yamashita,
Date of Issue: 12-Sept-2022
Place of Issue: Regulatory Office, SunMed
Vice President Regulatory
Grand Rapids, Michigan, USA
This declaration of conformity is issued under the sole responsibility of SunMed. We hereby declare that the medical device(s) specified above meet the provision of the Regulation (EU) MDR 2017/745 for medical devices. All technical documentation is retained at the premises of the manufacturer/technical documentation location.
Doc #: FRM-10002 Rev 3
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DECLARATION OF CONFORMITY DOC-20017a Oxygen Cannulas
SRN: US-MF-000007934 Basic UDI: 006074TF1005_Cannulas27
UDI # GTIN
Model Number -- Case Qty
Description
00607411101144 10607411101141 00607411008269 30607511008260 00607411101267 10607411101264 00607411101113 10607411101110 00607411008368 10607411008365 00607411101694 10607411101691 00607411101496 10607411101493 00607411101175 10607411101172 00607411101212 10607411101219 00607411101168 10607411101165 00607411101236 10607411101233 00607411300714 10607411300711 00607411101687 10607411101684 00607411101250 10607411101257 00607411102042 00607411919077 30607411919078 00607411919084 30607411919085 00607411919091 30607411919092 00607411919107 40607411919105 00607411919114 30607411919115 00607411919121 30607411919122 00607411919138 30607411919139
1053-25 1053-25-25 1005255 1005255-50 1053-4 1053-4-50 1053-7 1053-7-50
Nasal Cannula (Adult), 25’ (7.6 m) supply tube
Nasal Cannula, Adult, 7’ (2.1m) tubing
Nasal Cannula (Adult), 4’ (1.2 m) supply tube
Nasal Cannula (Adult), 7’ (2.1 m) supply tube
1053TLC-14 1053TLC-14-25 1053TLC-7 1053TLC-7-25 1056-1 1056-1-50 1056-10 1056-10-50 1056-4 1056-4-50 1056-7 1056-7-50 1057-0 1057-0-50 1057B-0 1057B-0-50 1057TLC-0 1057TLC-0-25 1068-16 1068-16-50
Nasal Cannula (Adult) TLCannula, 14’ (4.2 m) supply tube
Nasal Cannula (Adult) TLCannula, 7’ (2.1 m) supply tube
Nasal Cannula (Adult), 1’ (0.3 m) supply tube
Nasal Cannula (Adult), 10’ (3.0 m) supply tube
Nasal Cannula (Adult), 4’ (1.2 m) supply tube
Nasal Cannula (Adult), 7’ (2.1 m) supply tube
Nasal Cannula (Adult) Salter Style, no supply tube
Nasal Cannula (Adult) Salter Style, no supply tube
Nasal Cannula (Adult) TLCannula, no supply tube
Nasal Cannula (Adult), 16’ (4.9 m) supply tube
1216
Nasal Cannula Adapter
13300 13300-50 13301 13301-50 13304 13304-50 13307 13307-30 13308 13308-50 13309 13309-50 13310 13310-50
Nasal Cannula (Adult) Salter Style, 7’ (2.1 m) supply tube for oxygen flows up to 6 LPM Nasal Cannula (Adult) Salter Style, 7’ (2.1 m) 02 supply tube, female thread grip connector. Nasal Cannula (Adult) Salter Style, 14’ (4.3 m) supply tube.
Nasal Cannula (Adult) Salter Style, 30’ (9.1 m) supply tube.
Nasal Cannula (Adult) Salter Style, 7’ (2.1 m) supply tube for oxygen flows up to 8 LPM. Nasal Micro Cannula (Adult) Salter Style, 7’ (2.1 m) 0-3 LPM supply tube Nasal Cannula (Adult) Salter Style, 7’ (2.1 m) supply tube.
Doc #: FRM-10002 Rev 3
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DECLARATION OF CONFORMITY DOC-20017a Oxygen Cannulas
SRN: US-MF-000007934 Basic UDI: 006074TF1005_Cannulas27
UDI # GTIN
Model Number -- Case Qty
Description
00607411919145 30607411919146 00607411919152 30607411919153 00607411919169 30607411919160 00607411919176 30607411919177 00607411919183 30607411919184 00607411100000 10607411100007 00607411100017 10607411100014 00607411100031 10607411100038 00607411000048 10607411100499 00607411100055 10607411100052 00607411100062 10607411100069 00607411100079 10607411100076 00607411100109 10607411100106 00607411100116 10607411100113 00607411100123 10607411100122 00607411100147 10607411100144 00607411100154 10607411100151 00607411100161 10607411100168 00607411100178 10607411100175 00607411100185 10607411100182 00607411100192 10607411100199 00607411100208 10607411100205
13320 13320-50 13321 13321-50 13322 13322-50 13323 13323-50 13324 13324-50 1600-1 1600-1-50 1600-10 1600-10-50 1600-12 1600-12-50 1600-13 1600-13-50 1600-14 1600-14-50 1600-15 1600-15-50 1600-16 1600-16-50 1600-2 1600-2-50 1600-20 1600-20-50 1600-21 1600-21-50 1600-24 1600-24-50 1600-25 1600-25-50 1600-3 1600-3-50 1600-30 1600-30-20 1600-35 1600-35-20 1600-4 1600-4-50 1600-40 1600-40-20
Nasal Cannula (Premature) Salter Style, 7’ (2.1 m) supply tube. Nasal Cannula (Neonate) Salter Style, 7’ (2.1 m) supply tube. Nasal Cannula (Infant) Salter Style, 7’ (2.1 m) supply tube. Nasal Cannula (Intermediate Infant) Salter Style, 7’ (2.1 m) supply tube. Nasal Cannula (Pediatric) Salter Style, 7’ (2.1 m) supply tube. Nasal Cannula (Adult) Salter Style, 1’ (0.3 m) supply tube
Nasal Cannula (Adult) Salter Style, 10’ (3.0 m) supply tube
Nasal Cannula (Adult) Salter Style, 12’ (3.65 m) supply tube
Nasal Cannula (Adult) Salter Style, 13’ (4.0 m) supply tube
Nasal Cannula (Adult) Salter Style, 14’ (4.3 m) supply tube
Nasal Cannula (Adult) Salter Style, 15’ (4.6 m) supply tube
Nasal Cannula (Adult) Salter Style, 1’ (0.3 m) supply tube
Nasal Cannula (Adult) Salter Style, 2’ (0.6 m) supply tube
Nasal Cannula (Adult) Salter Style, 20’ (6.1 m) supply tube
Nasal Cannula (Adult) Salter Style, 21’ (6.4 m) supply tube
Nasal Cannula (Adult) Salter Style, 24’ (7.3 m) supply tube
Nasal Cannula (Adult) Salter Style, 25’ (7.6 m) supply tube
Nasal Cannula (Adult) Salter Style, 3’ (0.9 m) supply tube
Nasal Cannula (Adult) Salter Style, 30’ (9.1 m) supply tube
Nasal Cannula (Adult) Salter Style, 35’ (10.7 m) supply tube
Nasal Cannula (Adult) Salter Style, 4’ (1.2 m) supply tube
Nasal Cannula (Adult) Salter Style, 40’ (12.2 m) supply tube
Doc #: FRM-10002 Rev 3
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DECLARATION OF CONFORMITY DOC-20017a Oxygen Cannulas
SRN: US-MF-000007934 Basic UDI: 006074TF1005_Cannulas27
UDI # GTIN
Model Number -- Case Qty
Description
00607411100222 10607411100229 00607411100239 10607411100236 00607411100253 10607411100250 00607411100277 10607411100274 00607411101809 10607411101806 00607411891823 10607411891820 00607411801204 10607411801201 00607411801280 10607411801287 00607411102011 10607411102018 20607411101780 00607411000386 00607411000383 00607411101656 10607411101653 00607411102066 00607411102011 00607411101649 10607411101646 20607411101643 00607411101632 00607411101639 00607411101625 10607411101622 20607411101629 00607411006616 10607411006613 00607411006128 10607411006125 00607411005923 20607411005927 00607411100376 10607411100373 00607411100321 10607411100328
1600-5 1600-5-50 1600-50 1600-50-20 1600-7 1600-7-50 1600-9 1600-9-50 1600G-10 1600G-10-50 1600G-25 1600G-25-25
Nasal Cannula (Adult) Salter Style, 5’ (1.5 m) supply tube
Nasal Cannula (Adult) Salter Style, 50’ (15.2 m) supply tube
Nasal Cannula (Adult) Salter Style, 7’ (2.1 m) supply tube
Nasal Cannula (Adult) Salter Style, 9’ (2.7 m) supply tube
Nasal Cannula (Adult) Salter Style, 10’ (3.0 m) green supply tube Nasal Cannula (Adult) Salter Style, 25’ (7.6 m) green supply tube Nasal Cannula (Adult) TLCannula, 14’ (4.3 m), green supply tube Nasal Cannula (Adult) TLCannula, 7’ (2.1 m) green supply tube Nasal Cannula (Adult) High Flow, 14’ (4.3 m) 0 to 15 LPM supply tube Nasal Cannula (Adult) High Flow, 15’ (4.6 m) 0-15 LPM supply tube Nasal Cannula (Adult) High Flow, 25’ (7.6 m) 0-15 LPM supply tube Nasal Cannula (Adult) High Flow, 40’ (12.2 m) 0-15 LPM supply tube Nasal Cannula (Adult) High Flow, 4’ (1.2 m) 0-15 LPM supply tube Nasal Cannula (Adult) High Flow, 50’ (15.2 m) 0-15 LPM supply tube Nasal Cannula (Adult) High Flow, 7’ (2.1 m) 0-15 LPM supply tube Nasal Cannula (Adult) High Flow, 25’ (7.6 m) supply tube, for flows up to 15 LPM Nasal (Adult) High Flow TLCannula, 7’ (2.1 m) supply tube Nasal Cannula (Adult) Salter Style, 14’ (4.3 m) 0-8 LPM supply tube Nasal Cannula (Adult) Salter Style, 25’ (7.6 m) 0-8 LPM supply tube Nasal (Adult) High Flow TLCannula, 14’ (2.1 m) supply tube
1600GTLC-14 1600GTLC-14-25 1600GTLC-7 1600GTLC-7-25 1600HF-14- 1600HF-14-10 1600HF-14-25 1600HF-15 1600HF-15-25 1600HF-25 1600HF-25-10 1600HF-40 1600HF-40-10 1600HF-4 1600HF-4-10 1600HF-4-25 1600HF-50 1600HF-50-10 1600HF-7- 1600HF-7-10 1600HF-7-25 1600HFTLC-14 1600HFTLC-14-25 1600HFTLC-25 1600HFTLC-25-10 1600HFTLC-7 1600HFTLC-7-25
1600Q-14 1600Q-14-50 1600Q-25 1600Q-25-25
Doc #: FRM-10002 Rev 3
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DECLARATION OF CONFORMITY DOC-20017a Oxygen Cannulas
SRN: US-MF-000007934 Basic UDI: 006074TF1005_Cannulas27
UDI # GTIN
Model Number -- Case Qty 1600Q-30 1600Q-30-20 1600Q-4 1600Q-4-50 1600Q-50 1600Q-50-20 1600Q-7 1600Q-7-25 1600Q-7-50 1600QTLC-7 1600QTLC-7-25 1600TLC-1 1600TLC-1-25 1600TLC-14 1600TLC-14-25 1600TLC-15 1600TLC-15-25 1600TLC-21 1600TLC-21-25 1600TLC-25 1600TLC-25-25 1600TLC-4 1600TLC-4-25 1600TLC-50 1600TLC-50-20 1600TLC-7 1600TLC-7-25
Description
00607411 100338 10607411100335 00607411100345 10607411100342 00607411100352 10607411100359 00607411100369 10607411100366 20607411100363 00607411101571 10607411101578 00607411101595 10607411101592 00607411101717 10607411101714 00607411101700 10607411101707 00607411102424 10607411102421 00607411101724 10607411101721 00607411101663 10607411101660 00607411101793 10607411101790 00607411101540 10607411101547 00607411101533 10607411101510 00607411101984 10607411101981 20607411101988 00607411100383 10607411100387 00607411100406 10607411100403 00607411100437 10607411100434 00607411008399 10607411008396 00607411101908 10607411101905 00607411100468 10607411100465
Nasal Cannula (Adult) Salter Style, 30’ (9.1 m) 0-8 LPM supply tube Nasal Cannula (Adult) Salter Style, 4’ (1.2 m) 0-8 LPM supply tube Nasal Cannula (Adult) Salter Style, 50’ (15.2 m) 0-8 LPM supply tube Nasal Cannula (Adult) Salter Style, 7’ (2.1 m) 0-8 LPM supply tube Nasal Cannula (Adult) TLCannula, 7’ (2.1 m) 0-8 LPM supply tube Nasal Cannula (Adult) TLCannula, 1’ (.3 m) supply tube.
Nasal Cannula (Adult) TLCannula, 14’ (4.3 m) supply tube.
Nasal Cannula (Adult) TLCannula, 15’ (4.6 m) supply tube.
Nasal Cannula (Adult) TLCannula, 21’ (6.4 m) supply tube.
Nasal Cannula (Adult) TLCannula, 25’ (7.6 m) supply tube.
Nasal Cannula (Adult) TLCannula, 4’ (1.2 m) supply tube.
Nasal Cannula (Adult) TLCannula, 50’ (15.2 m) supply tube.
Nasal Cannula (Adult) TLCannula, 7’ (2.1 m) supply tube.
1601-1 1600-1-50 1601-4 1601-4-25 1601-4-50 1601-7 1601-7-50
Nasal Cannula (Infant) Salter Style, 1’ (0.3 m) supply tube
Nasal Cannula (Infant) Salter Style, 4’ (1.2 m) supply tube
Nasal Cannula (Infant) Salter Style, 7’ (2.1 m) supply tube
1601Q-14 1601Q-14-50 1601Q-7 1601Q-7-50 1601TG-7 1601TG-7-50 1602-10 1602-10-50
Nasal Cannula (Infant) Salter Style, 14’ (4.3 m) supply tube
Nasal Cannula (Infant) Salter Style, 7’ (2.1 m) supply tube
Nasal Cannula (Infant) Salter Style, 7’ (2.1 m) supply tube
Nasal Cannula (Pediatric) Salter Style, 10’ (3 m) supply tube
1602-1 1602-1-50
Nasal Cannula (Pediatric) Salter Style, 1’ (0.3 m) supply tube
Doc #: FRM-10002 Rev 3
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DECLARATION OF CONFORMITY DOC-20017a Oxygen Cannulas
SRN: US-MF-000007934 Basic UDI: 006074TF1005_Cannulas27
UDI # GTIN
Model Number -- Case Qty 1602-25 1602-25-25 1602-4 1602-4-50 1602-7 1602-7-25 1602-7-50 1602-9 1602-9-50 1602TG-7 1602TG-7-50 1602TLC-7 1602TLC-7-25
Description
00607411100512 10607411100519 00607411101779 10607411101776 00607411100550 10607411100557 20607411100554 00607411100567 10607411100564 00607411100574 10607411100571 00607411101618 10607411101615 00607411100581 10607411100588 00607411102004 10607411102001 00607411301421 10607411301428 00607411100598 10607411100595 00607411101564 10607411101561 00607411100611 10607411100618 20607411100615 00607411100628 10607411100625 20607411100622 00607411100635 10607411100632 20607411100639 30607411100636 20607411100639 00607411100642 10607411100649 00607411100659 10607411100656 20607411100653 00607411100673 10607411100670 20607411100677 00607411100697 10607411100694
Nasal Cannula (Pediatric) Salter Style, 25’ (7.6 m) supply tube Nasal Cannula (Pediatric) Salter Style, 4’ (1.2 m) supply tube Nasal Cannula (Pediatric) Salter Style, 7’ (2.1 m) supply tube Nasal Cannula (Pediatric) Salter Style, 9’ (2.7 m) supply tube Nasal Cannula (Pediatric) Salter Style, 7’ (2.1 m) supply tube, thread grip. Nasal Cannula (Pediatric) TLCannula, 7’ (2.1 m) supply tube.
1606-0 1606-0-50 1606B-0 1600B-0-50
Nasal Cannula (Adult) Salter Style, no supply tube
Nasal Cannula (Adult) Salter Style, no supply tube
1606BTLC-0 1606BTLC-0-25 1606Q-0 1606Q-0-50 1606TLC-0 1606TLC-0-25
Nasal Cannula (Adult) TLCannula, no supply tube.
Nasal Cannula (Adult) Salter Style, no supply tube
Nasal Cannula (Adult) TLCannula, no supply tube.
1610-7 1610-7-10 1610-7-50
Nasal Cannula (Premature) Salter Style, 7’ (2.1 m) supply tube Nasal Cannula (Premature) Salter Style, 7' (2.1 m) supply tube, Thread Grip
1610TG-7 1610TG-7-10 1610TG-7-50
1611-7 1611-7-10 1611-7-25 1611-7-50
Nasal Cannula (neonate) Salter Style, 7’ (2.1 m) supply tube
1611-7-25-HC 1611TG-7 1611TG-7-50
Nasal Cannula (neonate) Salter Style, 7’ (2.1 m) supply tube Nasal Cannula (neonate) Salter Style, 7’ (2.1 m) supply tube, thread grip Nasal Cannula (Intermediate Infant) Salter Style, 7’ (2.1 m) supply tube Nasal Micro Cannula (Adult) Salter Style, 1’ (0.3 m) supply tube Nasal Micro Cannula (Adult) Salter Style, 3’ (0.9 m) 0-3 LPM supply tube
1615-7 1615-7-25 1615-7-50 1616-1 1616-1-25 1616-1-50 1616-3 1616-3-50
Doc #: FRM-10002 Rev 3
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DECLARATION OF CONFORMITY DOC-20017a Oxygen Cannulas
SRN: US-MF-000007934 Basic UDI: 006074TF1005_Cannulas27
UDI # GTIN
Model Number -- Case Qty
Description
00607411100703 10607411100700 20607411100707 00607411100710 10607411100717 00607411100727 10607411100724 00607411101600 10607411101678 00607411101588 10607411101588 00607411100734 10607411100731 00607411110771 10607411110778 00607411100789 10607411100786 00607411100802 10607411100809 00607411100833 10607411100830 00607411100864 10607411100861 00607411100888 10607411100885 00607411100895 10607411100892 00607411101748 10607411101745 00607411100925 10607411100922 00607411100956 10607411100953 00607411891731 10607411891738 00607411100970 10607411100977 00607411100994 10607411100991 00607411101007 10607411101004 00607411101014 10607411101011
1616-4 1616-4-25 1616-4-50 1616-7 1616-7-50
Nasal Micro Cannula (Adult) Salter Style, 4’ (1.2 m) 0-3 LPM supply tube Nasal Micro Cannula (Adult) Salter Style, 7’ (2.1 m) 0-3 LPM supply tube Nasal Cannula (Adult) Salter Style, 7' (2.1 m) supply tube, female thread grip connector Nasal Micro Cannula (Adult) TLCannula, 4' (1.2 m) 0-3 LPM supply tube Nasal Micro Cannula (Adult) TLCannula, 7' (2.1 m) 0-3 LPM supply tube Nasal Cannula (Adult) Salter Style, 10’ (3.0 m) supply tube
1616TG-7 1616TG-7-50 1616TLC-4 1616TLC-4-25 1616TLC-7 1616TLC-7-25 1650-10 1650-10-50 1650-14 1650-14-50 1650-15 1650-15-50 1650-20 1650-20-25 1650-25 1650-25-25 1650-4 1650-4-50 1650-50 1650-50-20 1650-7 1650-7-50 1650HF-50 1650HF-50-10 1650Q-7 1650Q-7-50
Nasal Cannula (Adult) Salter Style, 14’ (4.3 m) supply tube
Nasal Cannula (Adult) Salter Style, 15’ (4.6 m) supply tube
Nasal Cannula (Adult) Salter Style, 20’ (6.1 m) supply tube
Nasal Cannula (Adult) Salter Style, 25’ (7.6 m) supply tube
Nasal Cannula (Adult) Salter Style, 4’ (1.2 m) supply tube
Nasal Cannula (Adult) Salter Style, 50’ (15.2 m) supply tube
Nasal Cannula (Adult) Salter Style, 7’ (2.1 m) supply tube
Nasal Cannula (Adult) High Flow, 50’ (15.2 m) supply tube, up to 15 LPM Nasal Cannula (Adult) Salter Style, 7’ (2.1 m) supply tube, up to 8 LPM Nasal Cannula (Infant) Salter Style, 7’ (2.1 m) supply tube
1651-7 1651-7-50 1652-7 1652-7-50 1662-0 1662-0-50 1699-10 1699-10-50 1699-12 1699-12-50 1699-14 1699-14-50
Nasal Cannula (Pediatric) Salter Style, 7’ (2,1m) supply tube
Nasal Cannula (Pediatric) Salter Style, no supply tube, 2” connector Nasal Cannula (Adult) Salter Style, 10’ (3.0 m) supply tube, female thread grip connector Nasal Cannula (Adult) Salter Style, 12’ (3.65 m) supply tube, female thread grip connector Nasal Cannula (Adult) Salter Style, 14' (4.3 m) supply tube, female thread grip connector
Doc #: FRM-10002 Rev 3
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SRN: US-MF-000007934 Basic UDI: 006074TF1005_Cannulas27
UDI # GTIN
Model Number -- Case Qty 1699-20 1699-20-25 1699-25 1699-25-25 1699-50 1699-50-20 1699-7 1699-7-50 1699G-10 1699G-10-50 1699TLC-10 1699TLC-10-25 1699TLC-10-50 1699TLC-7 1699TLC-7-25 16SOFT-0 16SOFT-0-50 16SOFT-1-50 16SOFT-14 16SOFT-14-50 16SOFT-2 16SOFT-2-50 16SOFT-25 16SOFT-25-25 16SOFT-4 16SOFT-4-50 16SOFT-7 16SOFT-7-50 16SOFT-B-0 16SOFT-B-0-50 16SOFT-HF-14 16SOFT-HF-14-25 16SOFT-HF-25 16SOFT-HF-25-10 16SOFT-HF-7 16SOFT-HF-7-25 16SOFT-INF-7 16SOFT-INF-7-50 16SOFT-NEO-7 16SOFT-NEO-7-50 16SOFT-PED-14 16SOFT-PED-14-50
Description
00607411101038 10607411101035 00607411101052 10607411101059 00607411101083 10607411101080 00607411101090 10607411101097 0060741110185 10607411101820 00607411101830 10607411101837 20607411101834 00607411101755 10607411101752 00607411916014 10607411916011 00607411919930 00607411915840 10607411915847 00607411918032 10607411918039 00607411915857 10607411915854 00607411915833 10607411915830 00607411915772 10607411915779 00607411917285 10607411917288 00607411915864 10607411915861 00607411915871 10607411915878 00607411915786 10607411918466 00607411952609 10607411952606 00607411952623 10607411952620 00607411918469 10607411918466
Nasal Cannula (Adult) Salter Style, 20' (6.1 m) supply tube, female thread grip connector Nasal Cannula (Adult) Salter Style, 25' (7.6 m) supply tube, female thread grip connector Nasal Cannula (Adult) Salter Style, 50’ (15.2 m) supply tube, female thread grip connector Nasal Cannula (Adult) Salter Style, 7' (2.1 m) supply tube, female thread grip connector Nasal Cannula (Adult) Salter Style, 10' (3.0 m) supply tube, female thread grip connector (Green) Nasal Cannula (Adult) TLCannula, 10’ (3 m) supply tube, female thread grip connector Nasal Cannula (Adult) TLCannula, 7’ (2.1 m) supply tube, female thread grip connector Nasal Cannula (Adult) Salter Style, no supply tube Nasal Cannula (Adult) Salter Style, 1' (0.31 m), 0 to 6 LPM supply tube Nasal Cannula (Adult) Salter Style, 14' (4.3 m) 0 to 6 LPM supply tube Nasal Cannula (Adult) Salter Style, 2' (0.61 m) 0 to 6 LPM supply tube Nasal Cannula (Adult) Salter Style, 25' (7.6 m) 0 to 6 LPM supply tube Nasal Cannula (Adult), 4' (1.2 m), 0 to 6 LPM supply tube
Nasal Cannula (Adult), 7' (2.1 m), 0 to 6 LPM supply tube
Nasal Cannula (Adult) Salter Style, no supply tube
Nasal Cannula (Adult) Salter Style, high flow, 14’ (4.3 m), 0 to 15 LPM supply tube Nasal Cannula (Adult) Salter Style high flow, 25’ (7.6 m), 0 to 15 LPM supply tube Nasal Cannula (Adult) Salter Style, high flow, 7’ (2.1 m), 0 to 15 LPM supple tube Nasal Cannula (Infant) Salter Style, 7’ (2.1 m) supply tube
Nasal Cannula (neonate) Salter Style, 7’ (2.1 m) supply tube
Nasal Cannula (Pediatric) Salter Style, 14' (4.3 m) 0 to 6 LPM supply tube
Doc #: FRM-10002 Rev 3
Page 8 of 11
2797
DECLARATION OF CONFORMITY DOC-20017a Oxygen Cannulas
SRN: US-MF-000007934 Basic UDI: 006074TF1005_Cannulas27
UDI # GTIN
Model Number -- Case Qty 16SOFT-PED-4 16SOFT-PED-4-50 16SOFT-PED-7 16SOFT-PED-7-50 16SOFT-PRE-7 16SOFT-PRE-7-50 16SOFT-TOD-7 16SOFT-TOD-7-50 16SOFTTG-14 16SOFTTG-14-50 16SOFTTG-25 16SOFTTG-25-25 16SOFTTG-7 16SOFTTG-7-50 16SOFTTG-HF-14 16SOFTTG-HF-14-25 16SOFTTG-HF-25-10 16SOFTTG-HF-7 16SOFTTG-HF-7-25 16SOFTTG-INF-7 16SOFTTG-INF-7-50 16SOFTTG-NEO-7 16SOFTTG-NEO-7-50 16SOFTTG-PED-14 16SOFTTG-PED-14-50 16SOFTTG-PED-7 16SOFTTG-PED-7-50 16SOFTTG-PRE-7 16SOFTTG-PRE-7-50
Description
00607411918476 10607411918473 00607411918483 10607411918480 00607411952613 10607411952616 00607411952630 10607411952637 00607411102301 10607411102308 00607411102318 10607411102315 00607411102288 10607411110228 00607411102400 10607411102407 00607411102417 00607411102394 10607411102391 00607411952647 10607411952644 00607411959615 10607411959612 00607411102387 10607411102384 00607411102370 10607411102377 00607411952593 10607411952590 00607411000102 10607411000109 00607411005473 10607411005470 00607411000119 10607411000116 00607411919435 30607411919436 00607411400629 10607411400626 20607411400623 30607411400620 00607411400872 10607411400879
Nasal Cannula (Pediatric) Salter Style, 4' (1.2 m) 0 to 6 LPM supply tube Nasal Cannula (Pediatric) Salter Style, 7' (2.1 m) 0 to 6 LPM supply tube Nasal Cannula (Premature) Salter Style, 7’ (2.1 m) supply tube supply tube Nasal Cannula (Intermediate Infant) Salter Style, 7’ (2.1 m) supply tube Nasal Cannula (Adult) Salter Style, 14' (4.3 m) 0 to 6 LPM supply tube Nasal Cannula (Adult) Salter Style, 25' (7.6 m) 0 to 6 LPM supply tube Nasal Cannula (Adult) Salter Style, 14' (4.3 m) 0 to 6 LPM supply tube Nasal Cannula (Adult) Salter Style, high flow, 14’ (4.3 m), 0 to 15 LPM supply tube Nasal Cannula (Adult) Salter Style, high flow, 25’ (7.6 m), 0 to 15 LPM supply tube Nasal Cannula (Adult) Salter Style, high flow, 7’ (2.1 m), 0 to 15 LPM supply tube Nasal Cannula (Infant) Salter Style, 7’ (2.1 m) supply tube Nasal Cannula (Neonate) Salter Style, 7’ (2.1 m) supply tube Salter Style Nasal Cannula (Pediatric), 14' (4.3 m) 0 to 6 LPM supply tube Salter Style® Nasal Cannula (Pediatric), 7' (2.1 m) 0 to 6 LPM supply tube Nasal Cannula (Premature) Salter Style, 7’ (2.1 m) supply tube Patient Kit. (1) Nipple Nut (6) Adult Nasal Cannula (1) Oxygen Tubing (1) Swivel Connector (2) No Smoking Sign Patient Kit. (1) Nipple Nut (6) Adult Nasal Cannula (1) Oxygen Tubing (1) Swivel Connector (2) No Smoking Sign Patient Kit. (2) Nipple Nut (2) Tubing Connector (6) Adult Nasal Cannula (1) Oxygen Tubing (1) No Smoking Sign
2252G-25 2252G-25-10 22GSOFT-25 22GSOFT-25-10 2402G-40 2402G-40-10 251-5030 251-5030-50 4804-4-4 4804-4-4-10 4804-4-4-25 4804-4-4-300 4804TLC-4-4 4804TLC-4-4-10
Nasal Cannula (Adult), 7’ (2.1 m) supply tube
Demand Nasal Cannula (Adult), 4’ (1.2m) supply tube, dual port demand valve
Demand Nasal TLCannula (Adult), 4’ (1.2m) supply tube, dual port demand valve
Doc #: FRM-10002 Rev 3
Page 9 of 11
2797
DECLARATION OF CONFORMITY DOC-20017a Oxygen Cannulas
SRN: US-MF-000007934 Basic UDI: 006074TF1005_Cannulas27
UDI # GTIN
Model Number -- Case Qty 4804TLC-4-4-25
Description
20607411400876 00607411400827 10607411400824 00607411007989 10607411007986 00607411400636 10607411400633 20607411400630 00607411400889 10607411400886 00607411400674 10607411400671 20607411400678 00607411400681 10607411400688 20607411400685 00607411891687 10607411891684 00607411891694 10607411891691 00607411891700 10607411891707 00607411889493 10607411889490 00607411889738 10607411889735 00607411917981 10607411917988 00607411918001 10607411918008 00607411940668 10607411940665 00607411940675 10607411940672 00607411918018 10607411918015 00607411201004 10607411201001 00607411200991 10607411200998 00607411201011 10607411201018
4805-5-5 4805-5-5-25
Demand Nasal Cannula (Adult), 5’ (1.5m) supply tube, dual port demand valve Demand Nasal TLCannula (Adult), 5’ (1.5m) supply tube, dual port demand valve Demand Nasal Cannula (Adult), 7’ (2.1 m) supply tube, dual port demand valve Demand Nasal TLCannula (Adult), 7’ (2.1 m) supply tube, dual port demand valve Demand Nasal Cannula (Pediatric), 4’ (1.2m) supply tube, dual port demand valve Demand Nasal Cannula (Pediatric), 7’ (2.1 m) supply tube, dual port demand valve Demand Nasal Cannula (Adult), 4’ (1.2m) supply tube, dual port demand valve Demand Nasal Cannula (Adult), 5’ (1.5m) supply tube, dual port demand valve Demand Nasal Cannula (Adult), 7’ (2.1 m) supply tube, dual port demand valve Demand Nasal Cannula (Adult), dual port demand valve
4805TLC-5-5 4805TLC-5-5-10
4807-7-7 4807-7-7-10 4807-7-7-25
4807TLC-7-7 4807TLC-7-7-25
4824-4-4 4824-4-4-10 4824-4-4-25 4827-7-7 4827-7-7-10 4827-7-7-25 4904-4-4 4904-4-4-25 4905-5-5 4905-5-5-25 4907-7-7 4907-7-7-25
B-70190-00 B-70190-00-25 (SO-405) B-701931-00 B-701901-00-25 (SO-404) DM3100 (SO-1964) DM3100-25 DM5500 (SO-1966) DM5500-25 DM6100 (SO-2053) DM6100-25 DM7100 (SO-2054) DM7100-25 DR1161 (SO-1967) DR1161-50
Demand Nasal Cannula (Adult), dual port demand valve
Nasal Pressure Monitoring Cannula (Adult), 7' (2.1 m) supply tube Nasal Pressure Monitoring Cannula (Adult), 7' (2.1 m) supply tube, male female connector Oral/Nasal Pressure Monitoring Cannula (Adult), 7’ (2.1 m) supply tube, male Luer style connection Oral/Nasal Pressure Monitoring Cannula (Adult), 7’ (2.1 m) supply tube, filter
Nasal Cannula (Adult), 7' (2.1 m) supply tube
L1600 L1600-50 L1601-7 L1601-7-50 L1602-7 L1602-7-50
Nasal Cannula (Adult) Salter Style, 7’ (2.1 m) supply tube
Nasal Cannula (Infant) Salter Style, 7’ (2.1 m) supply tube
Nasal Cannula (Pediatric) Salter Style, 7’ (2.1 m) supply tube
Doc #: FRM-10002 Rev 3
Page 10 of 11
2797
DECLARATION OF CONFORMITY DOC-20017a Oxygen Cannulas
SRN: US-MF-000007934 Basic UDI: 006074TF1005_Cannulas27
UDI # GTIN
Model Number -- Case Qty
Description
10607411000055 10607411945363
M037367 M049562
Nasal Cannula (Adult), 4’ (1.2 m) supply tube
Nasal Cannula (Adult) Salter Style, 7' (2.1 m) 0 to 6 LPM supply tube Nasal Cannula (Adult) Salter Style 7’ (2.1 m), 0 to 8 LPM supply tube Nasal Micro Cannula (Adult) Salter Style, 4’ (1,2 m) 0-3 LPM supply tube Nasal Micro Cannula (Adult), 4' (1.2 m) 0-3 LPM supply tube Nasal Cannula (Pediatric), 7’ (2.1 m) supply tube Nasal Cannula (Adult) Salter Style, 7’ (2.1 m) supply tube
00607411888731
M3110
00607411888748
M3115
00607411888755
M3117
00607411888724 00607411100246 10607411100243 00607422891812 00607411918117 00607411918124 00607411961045 10607411961042 00607411961052 10607411961059 00607411101526 10607411101523 30607411008260
M3120
SO-1945 SO-1945-5 SO-1975
Nasal Cannula (Neonate), 1” supple tube Nasal Cannula (Infant), 1" supply tube Nasal Cannula (Pediatric), 1" supply tube
SO-1976 SO-1977
SO-2085 SO-2085-50 SO-2086 SO-2086-50 SO-406-0 SO-406-50
Salter Style® Nasal Cannula (Adult), 4' (1.2 m) 0 to 6 LPM supply tube Salter Style® Nasal Cannula (Adult), 7' (2.1 m) 0 to 6 LPM supply tube Nasal Cannula (adult) Salter Style, 7’ (2.1 m) supply tube
1005255
Nasal Cannula (Adult)
Doc #: FRM-10002 Rev 3
Page 11 of 11
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