Quantum PureFlow KIT CPC – Hansen Connector Adaptor

2 catalogue numbers from CONN-HX2, listed by Spectrum Medical Ltd, United Kingdom, under Accessory Equipment, Cardiopulmonary Bypass. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

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 Quantum PureFlow KIT CPC – Hansen Connector Adaptor
Listed by Spectrum Medical Ltd, United Kingdom
FDA product code KRI
Device type Accessory Equipment, Cardiopulmonary Bypass
Device class Class 1
Regulation 21 CFR 870.4200
Establishment Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-05-18
Record revised 2024-01-05 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Quantum PureFlow KIT CPC – Hansen Connector Adaptor
Catalogue number Size Status
CONN-HX2 In distribution
CONN-HX2 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