FDA UDI
In Commercial Distribution
🇺🇸 United States
AMICUS Separator
DI: 00810020440232
·
Model: 6R4590TH-T
·
Fresenius Kabi AG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AMICUS Separator
- Primary DI
- 00810020440232
- Version / Model
- 6R4590TH-T
- Catalog Number
- 6R4590TH-T
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-20
- Public Version
- 1
- Public Version Date
- 2020-10-28
- Public Version Status
- New
- Public Device Record Key
- bfd7adbe-ead9-44c9-8a76-257c8b4c13c1
Device Description
The AMICUS Separator is an automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GKT | Separator, Automated, Blood Cell, Diagnostic | Hematology | 864.9245 | 2 |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16405 | Apheresis system | An assembly of electrically-powered devices designed for the extracorporeal separation and removal of a constituent of whole blood (e.g., plasma, platelets, leukocytes) and pathogens, and the return of the remaining constituents to the patient. It typically includes pumps to circulate the blood and uses methods such as membrane filtration, centrifugation, adsorption, or a combination of these to separate the constituent from the blood. The system may be used therapeutically (e.g., to remove immune complexes or low density lipoproteins) or for the harvesting of blood constituents (e.g., for HLA-matched platelets or fresh frozen plasma). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810020440232 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200530 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage and Handling as defined on Label