Primary Device ID | 20811137010701 |
NIH Device Record Key | 312db0ab-9cd7-453a-83ee-763111e560be |
Commercial Distribution Discontinuation | 2018-05-28 |
Commercial Distribution Status | Not in Commercial Distribution |
Version Model Number | 4C2243 |
Catalog Number | 4C2243 |
Company DUNS | 794519020 |
Company Name | FENWAL, INC. |
Device Count | 2 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00811137010707 [Unit of Use] |
GS1 | 10811137010704 [Primary] |
GS1 | 20811137010701 [Package] Contains: 10811137010704 Package: Box [48 Units] Discontinued: 2018-05-28 Not 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 | 3 |
Public Version Date | 2019-11-08 |
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 | 2019-11-08Plasma Transfer Sets with Two Spikes. Sterile Fluid Path |
20811137010701 - NA | 2019-11-08 Plasma Transfer Sets with Two Spikes. Sterile Fluid Path |