Identity
- Trade Name
- CATSmart FDA UDI
- Generic Name
- Autotransfusion system blood collection/processing pump FDA UDI
- Device Name
- The CATSmart (Continuous Autotransfusion System) by Fresenius is indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. FDA UDI
- Model / Reference
- 9005901 FDA UDI
- Description
- The CATSmart (Continuous Autotransfusion System) by Fresenius is indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. FDA UDI
Identifiers
- Catalog Number
- 9005901 FDA UDI
- Primary DI / UDI-DI
- 04086000860048 FDA UDI
- FDA Product Code
- CAC FDA UDI
- GMDN Term
- Autotransfusion system blood collection/processing pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5830 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Autotransfusion system blood collection/processing pump
CATSmart by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI 8d088e78-74c9-4591-a7f2-805a2295d824 36 fields · synced May 30, 2026