Medrad® Twist & Go Disposable Syringe 150 Ml With Quick Fill Tube

Twist & Go Syringe Kit, 150 ML (ANGIO - ARTERION, TWIST & GO150ML SYR w/QFT, MC) (60766817)

Registry build 21.09.26
2manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Guangdong (1).

Chinese manufacturers registered for FDA product code FPK
Manufacturer City Province Registered as Device types
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29

Record

Regulatory record for Medrad® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube
Listed by Bayer Medical Care Inc., United States
FDA product code FPK
Device type Tubing, Fluid Delivery
Device class Class 2
Regulation 21 CFR 880.5440
Establishment Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k) K131517
Record published 2016-09-24
Record revised 2018-07-06 (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
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 25, pack of 50

Catalogue Numbers

Catalogue numbers for Medrad® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube
Catalogue number Size Status
TAG 150 SYR In distribution
TAG 150 SYR In distribution
TAG 150 SYR In distribution
TAG 150 SYR In distribution
TAG 150 SYR In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
High Pressure Tubing Merit Medical Systems, Inc. 68
Vygon Vygon Corp. 67
Medex ICU Medical, Inc 41
High Pressure Tubing, Keep™ Merit Medical Systems, Inc. 25
Pressure Monitor Tubing Merit Medical Systems, Inc. 21
Medrad® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in) Bayer Medical Care Inc. 16
Merit Medical® Merit Medical Systems, Inc. 10
Kew Medical Douglas Medical Products, Inc 8
Merit Medical® Argon Critical Care Systems Singapore PTE. Ltd. 5
CIV Emed Technologies Corporation 5
Lifeshield ICU Medical, Inc 5
EZ-IV Emed Technologies Corporation 5

Showing 12 of 51. All products under Tubing, Fluid Delivery

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