Critikit™

3 catalogue numbers from 10884450320911, listed by Argon Critical Care Systems Singapore PTE. Ltd., under Probe, Thermodilution. 3 manufacturers in China are registered for this product code.

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

Who Else Makes It

Concentrated in Guangdong (1), Jiangsu (1), Shandong (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 KRB
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Bioxin Medical Co., Ltd. Weihai Shandong Contract manufacturer 8
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57

Record

Regulatory record for Critikit™
Listed by Argon Critical Care Systems Singapore PTE. Ltd.
FDA product code KRB
Device type Probe, Thermodilution
Device class Class 2
Regulation 21 CFR 870.1915
Record published 2018-01-30
Record revised 2021-12-13 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 10, pack of 4, pack of 2

Catalogue Numbers

Catalogue numbers for Critikit™
Catalogue number Size Per pack Status
10884450320911 5 In distribution
10884450557102 5 In distribution
10884450320904 4 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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Co-SET+ Edwards Lifesciences Technology Sarl 10
ICU Medical ICU Medical, Inc 9
PiCCO catheter Maquet Critical Care AB 5
PiCCO Monitoring Kit Pulsion Medical Systems SE 3
Criticath(TM) SP5105HL TD Catheter Argon Critical Care Systems Singapore PTE. Ltd. 1
Adler Instrument Company Adler, Inc. 1
Co Module w/ cable & accessory Shenzhen Mindray BIO-Medical Electronics Co., Ltd. 1
Criticath(TM) SP5507S TD Catheter Argon Critical Care Systems Singapore PTE. Ltd. 1
Criticath(TM) SP5507 TD Catheter Argon Critical Care Systems Singapore PTE. Ltd. 1
Criticath SP5507-13 TD Catheter Argon Critical Care Systems Singapore PTE. Ltd. 1

Showing 12 of 49. All products under Probe, Thermodilution

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