| Primary Device ID | B458206200000 |
| NIH Device Record Key | 0fd75a15-476d-4b6f-81d3-550a68a7c59b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wells Johnson HVP System |
| Version Model Number | 20620000 |
| Catalog Number | 20-6200-00 |
| Company DUNS | 048931625 |
| Company Name | The Wells Johnson Company |
| 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 | true |
| 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 |
|---|---|
| HIBCC | B458206200000 [Primary] |
| FRN | Pump, Infusion |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-24 |
| Device Publish Date | 2023-07-14 |
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| B458201314000 - DEL VECCHIO 12-HOLE, 4MM, 1" BLUE ERGO | 2025-08-05 Cannula, Del Vecchio 12-Hole, 4mm, 1" Blue Ergo Handle. |
| B458205186000 - Small Volume Harvesting Canister | 2025-02-13 Wells Johnson Small Volume Collection and Harvesting Canister, 250ml |
| B458205187000 - Small Volume Harvesting Canister | 2025-02-13 Wells Johnson Small Volume Collection and Harvesting Canister, 500ml |
| B458208300000 - HVC3™ | 2024-10-16 HVC3™ (High Volume Canister, 3L) |
| B458201266000 - FISCHER (ALOUF) | 2024-04-29 Cannula, Fischer (Alouf), specify length, diameter and handle/hub |
| B458201360000 - INFILTRATION CANNULA SET, WIS (2) | 2024-03-04 SET, CANNULA, INFILTRATION, WIS (2), contains: -Multi-Hole 6 13g x 25cm on dll (P/N: 20-1218-00) -Multi-Hole 6 14g x 17cm on dll |