Primary Device ID | 00811137012916 |
NIH Device Record Key | 6d84b13a-cbed-4e59-b69a-e1477129756c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ALYX Plasma Kit |
Version Model Number | 4R5730 |
Catalog Number | 4R5730 |
Company DUNS | 794519020 |
Company Name | FENWAL, INC. |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00811137012916 [Primary] |
GS1 | 10811137012913 [Package] Package: Carton [6 Units] In Commercial Distribution |
GKT | Separator, Automated, Blood Cell, Diagnostic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-08 |
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 |