Brevia Dialysis Catheter Kit

Brevia Catheter Kit, 20

Registry build 21.09.26
1manufacturer
4catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LFJ
Manufacturer City Province Registered as Device types
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17

Record

Regulatory record for Brevia Dialysis Catheter Kit
Listed by Bard Access Systems, Inc., United States
FDA product code LFJ
Device type Catheter, Subclavian
Device class Class 2
Regulation 21 CFR 876.5540
Establishment Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published 2015-09-23
Record revised 2024-09-26 (version 4)

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 Case of 5, box of 10
Sizes Catheter gauge 11 Fr; length 12.5 to 24 cm
Distribution end date 2024-01-08

Catalogue Numbers

Catalogue numbers for Brevia Dialysis Catheter Kit
Catalogue number Size Status
5563120 Catheter Gauge 11 Fr In distribution
5563240 Catheter Gauge 11 Fr In distribution
5563150 Catheter Gauge 11 Fr In distribution
5563200 Length 20 cm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Arrow Teleflex Medical LLC 45
Hemo-Cath® Medical Components Inc 37
SLX Hemo-Cath® Medical Components Inc 28
Permcath Mozarc Medical US LLC 9
Silicone Hemo-Cath-NO Cuff/Acutesilicone Hemo-Cath-NO Cuff/Acute Medical Components Inc 6
Brevia Short Term Dialysis Catheter Bard Access Systems, Inc. 4
Mahurkar Mozarc Medical US LLC 4
Argyle Mozarc Medical US LLC 4
Schon AngioDynamics, Inc. 4
Hemo-Cath® Silicone Medical Components Inc 3
Hemo-Cath®ij Medical Components Inc 2
Soft-Cell Dialysis Catheter Kit 12.5 F x 19 cm Bard Access Systems, Inc. 1

Showing 12 of 25. All products under Catheter, Subclavian

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