| Primary Device ID | 10811137012692 |
| NIH Device Record Key | 750605a6-363b-4135-892d-9877fc8b9668 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 4C2498H |
| Catalog Number | 4C2498H |
| Company DUNS | 794519020 |
| Company Name | FENWAL, INC. |
| 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 | true |
| Lot Batch | true |
| 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 |
| Phone | 1-800-933-6925 |
| xx@xx.xx | |
| Phone | 1-800-933-6925 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811137012695 [Primary] |
| GS1 | 10811137012692 [Package] Contains: 00811137012695 Package: Box [48 Units] In Commercial Distribution |
| KSB | Set, Transfer (Blood/Plasma) |
| 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 | 2016-09-12 |
| 20811137010626 - Transfer Pack | 2023-04-21 Quadruple Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path |
| 20811137010497 - Transfer Pack | 2022-06-17 Transfer Pack Container 1000 mL with Coupler. Sterile Fluid Path |
| 20811137010619 - Transfer Pack | 2022-06-17 Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path |
| 20811137010541 - Transfer Pack | 2019-11-08 Transfer Pack Container 300 mL with Coupler. Sterile Fluid Path |
| 0FE04R2024 - Transfer Pack | 2019-11-08 Transfer Pack Container 600 mL with Male Luer Adapter. Sterile Fluid Path |
| 20811137010633 - Transfer Pack | 2019-11-08 Transfer Pack Container 600 mL with Coupler. Sterile Fluid Path |
| 20811137010657 - NA | 2019-11-08 Plasma Transfer Sets with Spike and Male Luer Adapter. Sterile Fluid Path |
| 20811137010701 - NA | 2019-11-08 Plasma Transfer Sets with Two Spikes. Sterile Fluid Path |