| Primary Device ID | 20801741045114 |
| NIH Device Record Key | 35205384-4662-4ec5-88cd-18de482bcd00 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RetrO Catheter Repair Kit |
| Version Model Number | PRRK5 |
| Catalog Number | PRRK5 |
| Company DUNS | 044611812 |
| Company Name | Bard Access Systems, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741045110 [Primary] |
| GS1 | 10801741045117 [Package] Contains: 00801741045110 Package: CA [5 Units] In Commercial Distribution |
| GS1 | 20801741045114 [Package] Contains: 10801741045117 Package: BX [18 Units] In Commercial Distribution |
| NFK | Kit, repair, catheter, hemodialysis |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-12-04 |
| 00801741038464 - Niagara Slim-Cath catheter | 2026-02-05 12Fr Niagara PC 15cm Kit |
| 00801741038471 - Niagara Slim-Cath Catheter | 2026-02-05 12Fr Niagara PC 20cm Kit |
| 00801741038488 - Niagara Slim-Cath catheter | 2026-02-05 12Fr Niagara PC 24cm Kit |
| 00801741045141 - Niagara Slim-Cath catheter | 2026-02-05 12 Fr Niagara PC 12.5 cm Kit |
| 00801741045158 - Niagara Slim-Cath catheter | 2026-02-05 12Fr Niagara PC 15cm Kit |
| 10801741231275 - CentroVena One | 2026-02-02 CentroVena One™ Insertion System Central Venous Catheter |
| 10801741231282 - CentroVena One | 2026-02-02 CentroVena One™ Insertion System Central Venous Catheter |
| 10801741231305 - CentroVena One | 2026-02-02 CentroVena One™ Insertion System Central Venous Catheter |