| Primary Device ID | 07640168021160 |
| NIH Device Record Key | 75555e45-a202-42cd-8fce-21cdd32d31a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | alfapump Programming Kit IV |
| Version Model Number | 02402 |
| Company DUNS | 480401893 |
| Company Name | Sequana Medical NV, Ghent, Zweigniederlassung Zürich |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 07640168021160 [Primary] |
| SDQ | Alfapump System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-18 |
| Device Publish Date | 2025-08-08 |
| 07640168020507 - alfapump System | 2025-08-18 alfapump System (catalog number 01485) is composed of the following devices: 01473 - alfapump 01474 - Bladder Catheter 01478 - T |
| 07640168020521 - Smart Charger - Single Item Packaging | 2025-08-18 |
| 07640168020538 - Docking Station - Single Item Packaging | 2025-08-18 |
| 07640168020545 - Implant Accessories - Single Item Packaging | 2025-08-18 |
| 07640168020798 - Introducer Kit - Single Item Packaging | 2025-08-18 |
| 07640168020804 - Peritoneal Catheter SNCA-5262L - Single Item Packaging | 2025-08-18 |
| 07640168020828 - Tunneling Rod - Single Item Packaging | 2025-08-18 |
| 07640168020880 - alfapump - Single Item Packaging | 2025-08-18 |