| Primary Device ID | 00850014025113 |
| NIH Device Record Key | bbf00f3d-1bdd-4c17-ba32-cf69d35cbe34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APRO 70 SwiftCatheter |
| Version Model Number | FG-02133-125-AC |
| Catalog Number | APRO-70-125 |
| Company DUNS | 065914268 |
| Company Name | Alembic, LLC |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850014025113 [Primary] |
| NRY | Catheter, Thrombus Retriever |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-12 |
| Device Publish Date | 2025-03-04 |
| 00850014025236 - APRO 55 Swift Catheter | 2025-07-08 APRO 55 Catheter, Hoop Configuration |
| 00850014025243 - APRO 55 Intermediate Catheter | 2025-07-08 APRO 55 Catheter, Hoop Configuration |
| 00850014025274 - APRO 55 Swift Catheter | 2025-07-08 APRO 55 Catheter, Hoop |
| 00850014025281 - APRO 55 Intermediate Catheter | 2025-07-08 APRO 55 Catheter, Hooped Configuration |
| 00850014025113 - APRO 70 SwiftCatheter | 2025-03-12 |
| 00850014025113 - APRO 70 SwiftCatheter | 2025-03-12 |
| 00850014025120 - APRO 70 Swift Catheter | 2025-03-12 |
| 00850014025229 - APRO 70 Swift Catheter | 2025-03-12 |
| 00850014025267 - APRO 70 Swift Catheter | 2025-03-12 |