Primary Device ID | 00810020440232 |
NIH Device Record Key | bfd7adbe-ead9-44c9-8a76-257c8b4c13c1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AMICUS Separator |
Version Model Number | 6R4590TH-T |
Catalog Number | 6R4590TH-T |
Company DUNS | 315654579 |
Company Name | Fresenius Kabi AG |
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 | true |
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 |
Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810020440232 [Primary] |
GKT | Separator, Automated, Blood Cell, Diagnostic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-10-28 |
Device Publish Date | 2020-10-20 |
04086000100137 | Automated blood cell separator indicated for the collection of blood components and in therapeut |
04086000100120 | Automated blood cell separator indicated for the collection of blood components and in therapeut |
00810020440232 | The AMICUS Separator is an automated blood cell separator indicated for the collection of blood |
00810020440249 | The AMICUS Separator is an automated blood cell separator indicated for the collection of blood |
00810020440218 | The AMICUS Separator is an automated blood cell separator indicated for the collection of blood |