Critiflo(TM) TA1018 (30ML/HR)

30 cc Critiflo device

Registry build 21.09.26
5manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KRA
Manufacturer City Province Registered as Device types
Shanghai Wallaby Medical Technologies Co., Inc. Shanghai Shanghai Contract manufacturer 5
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Suzhou Zenith Vascular Scitech Limited Suzhou Jiangsu Manufacturer 6
Suzhou Hengrui Hongyuan Medical Co., Ltd. Suzhou Jiangsu Manufacturer 3
Vascupatent Medical (Shenzhen) Co., Ltd. Shenzhen Guangdong Manufacturer 1

Record

Regulatory record for Critiflo(TM) TA1018 (30ML/HR)
Listed by Argon Critical Care Systems Singapore PTE. Ltd.
FDA product code KRA
Device type Catheter, Continuous Flush
Device class Class 2
Regulation 21 CFR 870.1210
Record published 2016-09-30
Record revised 2018-06-11 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Packaging Tyvek pouch of 100

Catalogue Numbers

Catalogue numbers for Critiflo(TM) TA1018 (30ML/HR)
Catalogue number Size Status
682065 30 cc flow rate In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Fountain® Merit Medical Systems, Inc. 154
PulseSpray AngioDynamics, Inc. 149
Merit Maestro® Merit Medical Systems, Inc. 143
Phenom™ Catheter Cathera, Inc. 103
UniFuse AngioDynamics, Inc. 84
CXI Cook Incorporated 48
Uni-Fuse+ AngioDynamics, Inc. 32
Prowler Medos International Sàrl 27
Truwave, Vamp Edwards Lifesciences Technology Sarl 26
ICU Medical ICU Medical, Inc 21
Cantata Cook Incorporated 20
Truwave, Vamp Plus Edwards Lifesciences Technology Sarl 19

Showing 12 of 149. All products under Catheter, Continuous Flush

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