| Primary Device ID | 00810020441062 |
| NIH Device Record Key | e4748e37-3d05-4ca9-8152-b7d0dc49d14e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fenwal Hand Sealer |
| Version Model Number | 4R4454W |
| Catalog Number | 4R4454W |
| Company DUNS | 315654579 |
| Company Name | Fresenius Kabi AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810020441062 [Primary] |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-08 |
| Device Publish Date | 2025-04-30 |
| 00810020441062 - Fenwal Hand Sealer | 2025-05-08The Hand Sealer is used to provide a hermetic closure on Blood-Pack Unit tubings when used with the Fenwal Hand Sealer Clips, code 4R4418. |
| 00810020441062 - Fenwal Hand Sealer | 2025-05-08 The Hand Sealer is used to provide a hermetic closure on Blood-Pack Unit tubings when used with the Fenwal Hand Sealer Clips, co |
| 10810020441748 - Adaptive Nomogram Bottle | 2025-03-24 For the collection, storage, and shipment of plasma prior to fractionation. For the collection of blood components. Sterile flui |
| 00810020440560 - Aurora Xi | 2025-03-06 Aurora Xi Plasmapheresis System with Software Version 2.1 |
| 00810020442199 - Aurora Xi | 2025-03-06 Aurora Xi Plasmapheresis System with Software Version 2.0 |
| 10810020441380 - Plasmalink Bottle 1000 mL with locking luer adapter | 2025-01-23 For the collection of blood components. Sterile Fluid Path |
| 10810020440512 - Adaptive Nomogram Transfer Pack | 2024-12-20 For processing and/or storage of blood and blood components. Sterile Fluid Path |
| 00811505030450 - Ivenix Infusion System | 2024-12-16 Infusion Management System (IMS) |
| 00811505030467 - Ivenix Infusion System | 2024-12-16 Large Volume Pump (LVP) Software (order 1 per pump) |