MC3

Soft Flow Aortic 24 FR 8MM STRAIGHT BULB NON VENTED

Registry build 21.09.26
3manufacturers in China registered for this device type
19catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DWF
Manufacturer City Province Registered as Device types
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26

Record

Regulatory record for MC3
Listed by Michigan Critical Care Consultants, Inc.
FDA product code DWF
Device type Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class Class 2
Regulation 21 CFR 870.4210
Record published 2018-01-10
Record revised 2024-08-23 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Packaging Pack of 10

Catalogue Numbers

Catalogue numbers for MC3
Catalogue number Size Status
4950 In distribution
4948 In distribution
6386 In distribution
5767 In distribution
5768 In distribution
7072 In distribution
4949 In distribution
7071 In distribution
5843 In distribution
5841 In distribution
7080 In distribution
6392 In distribution
5761 In distribution
6384 In distribution
5762 In distribution
6394 In distribution
4951 In distribution
5798 In distribution
5842 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Medtronic, Inc. 5,237
DLP™ Medtronic, Inc. 804
Bio-Medicus™ Medtronic, Inc. 223
Pemco Inc Pemco, Inc. 137
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Maquet Cardiopulmonary GmbH 135
Venous cardiopulmonary bypass cannula LivaNova USA, Inc. 97
Eopa™ Medtronic, Inc. 87
Surge Cardiovascular MED Michigan Holdings LLC 80
Arterial cardiopulmonary bypass cannula LivaNova USA, Inc. 79
MC2™ Medtronic, Inc. 66
Select Series® Medtronic, Inc. 63
Edwards Lifesciences Aortic Perfusion Cannula Edwards Lifesciences Technology Sarl 52

Showing 12 of 372. All products under Catheter, Cannula And Tubing, Vascular, 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