Eight Medical

Myocardial temperature probe, 15mm needle, 8' length, 1/8" Plug

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 Eight Medical
Listed by MED Michigan Holdings LLC, United States
FDA product code KRI
Device type Accessory Equipment, Cardiopulmonary Bypass
Device class Class 1
Regulation 21 CFR 870.4200
Establishment Specification developer, Manufacturer
Record published 2018-02-20
Record revised 2022-09-21 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 25

Catalogue Numbers

Catalogue numbers for Eight Medical
Catalogue number Size Status
8510 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