Brevia Short Term Dialysis Catheter
DOT, Brevia Catheter
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.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
Record
| 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
| 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 |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 5 |
| Sizes | Catheter gauge 11 Fr; length 12.5 to 24 cm |
| Distribution end date | 2024-01-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5565120 | Catheter Gauge 11 Fr | In distribution |
| 5565200 | Length 20 cm | In distribution |
| 5565240 | Length 24 cm | In distribution |
| 5565150 | Length 15 cm | Withdrawn |
Same 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 |
| Mahurkar | Mozarc Medical US LLC | 4 |
| Argyle | Mozarc Medical US LLC | 4 |
| Brevia Dialysis Catheter Kit | Bard Access Systems, Inc. | 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.