DOC-20012a EU MDR InfuseIT Press Infusor DoC Rev 1

2797

DECLARATION OF CONFORMITY

SRN: US-MF-000007934

DOC-20012a InfuseIT Pressure Infusor

Basic UDI : 006074TF1030_InfusorWZ

InfuseIT Pressure Infusor A pressure infusor has an inflatable sleeve which is placed around an I.V. bag. When the device is inflated, it assists in the infusion of fluid.

Product Name: Intended Purpose:

Model Number or Designator:

See the following table of part numbers

Doc-20012a 12-Sept-2022

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. Route of conformity is according to (EU) MDR Annex IX Quality Management System A0599, Disposable Infusion Mechanical Systems, Accessories

Conformity Route:

EMDN Nomenclature code (CND):

13100 , Infusion Regulator, Pressure

Global Medical Device Nomenclature Code (GMDN): Universal Medical Device Nomenclature System (UMDNS):

13100, Pressure Infusor

Product Options/Accessories:

Options: See following table. Accessories: N/A .

MDR 738597

EC Certificate Number:

Notified Body:

BSI Group Inc., Notified Body CE 2797 Say Building John M. Keynesplein 9 1066 EP Amsterdam Netherlands www.bsigroup.com

MT Promedt Consulting GmbH Ernst-Heckel-Straße 7 66386 St. Ingbert Germany

Authorized EU Representative:

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

Page 1 of 2

2797

DECLARATION OF CONFORMITY

SRN: US-MF-000007934

DOC-20012a InfuseIT Pressure Infusor

Basic UDI : 006074TF1030_InfusorWZ

UDI # GTIN

Model Number -- Case Qty

Description

00607411911927 10607411911924 20607411911921 00607411913402 10607411913409 20607411913406 00607411916915 10607411916912 20607411916919 00607411911903 10607411911900 20607411911907 00607411915369 10607411915366 20607411915363 00607411913396 10607411913393 20607411913390 00607411911910 10607411911917 20607411911914 00607411916908 10607411952637 20607411916902

ZIT-500-1 ZIT-500-8 ZIT-500-10 ZIT-502-1 ZIT-502-8 ZIT-502-10 ZIT-520-1 ZIT-520-5 ZIT-520-10 ZIT-1000-1 ZIT-1000-8 ZIT-1000-10 ZIT-1002-1 ZIT-1002-8 ZIT-1002-10 ZIT-1020-1 ZIT-1020-5 ZIT-1020-8 ZIT-3000-1 ZIT-3000-8 ZIT-3000-10 ZIT-3002-1 ZIT-3002-8 ZIT-3002-10

InfuseIT 500ml Disposable Pressure Infusor

InfuseIT 500 ml Disposable Pressure Infusor

InfuseIT 500 ml Reusable Pressure Infusor

InfuseIT 1000 ml Disposable Pressure Infusor

InfuseIT 1000 ml Disposable Pressure Infusor

InfuseIT 1000 ml Reusable Pressure Infusor

InfuseIT 3000 ml Disposable Pressure Infusor

InfuseIT 3000 ml Disposable Pressure Infusor

Doc #: FRM-10002 Rev 3

Page 2 of 2