Exchanger

Catalogue number D611 Holder, listed by Sorin Group Italia SRL, under Accessory Equipment, Cardiopulmonary Bypass. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code KRI
Manufacturer City Province Registered as Device types
Lifemotion Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 2

Record

Regulatory record for Exchanger
Listed by Sorin Group Italia SRL
FDA product code KRI
Device type Accessory Equipment, Cardiopulmonary Bypass
Device class Class 1
Regulation 21 CFR 870.4200
Premarket notification Exempt
Record published 2023-10-24

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Exchanger
Catalogue number Size Status
D611 Holder In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bracket LivaNova USA, Inc. 16
Accessory Equipment, Cardiopulmonary Bypass Maquet Cardiopulmonary GmbH 15
VivaCart CardioQuip 14
Capiox Terumo Corp. 12
CentriMag™ Thoratec Corp. 11
LifeSPARC Cardiacassist, Inc. 9
Quantum Spectrum Medical Ltd 8
Surge Cardiovascular MED Michigan Holdings LLC 8
Terumo® Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation 6
Novatemp Novamed-USA 5
Inspire Sorin Group Italia SRL 5
Holder Eurosets SRL 4

Showing 12 of 108. All products under Accessory Equipment, Cardiopulmonary Bypass

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer