Identity
- Trade Name
- C.A.T.S FDA UDI
- Generic Name
- Red blood cell-recovery autotransfusion system FDA UDI
- Device Name
- The C.A.T.S (Continuous Autotransfusion System) device by Fresenius is an autotransfusion device 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
- 9005081 FDA UDI
- Description
- The C.A.T.S (Continuous Autotransfusion System) device by Fresenius is an autotransfusion device 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
- 9005081 FDA UDI
- Primary DI / UDI-DI
- 04086000860031 FDA UDI
- 510(k) Number
- K960006 FDA UDI
- FDA Product Code
- CAC FDA UDI
- GMDN Term
- Red blood cell-recovery autotransfusion system 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: Red blood cell-recovery autotransfusion system
C.a.t.s by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Red blood cell-recovery autotransfusion system.
- XTRA — SORIN GROUP ITALIA SRL · Class II
- BRAT 2 — SORIN GROUP ITALIA SRL · Class II
- XTRA — SORIN GROUP ITALIA SRL · Class II
- XTRA — SORIN GROUP ITALIA SRL · Class II
- BRAT 2 — SORIN GROUP ITALIA SRL · Class II
- XTRA — SORIN GROUP ITALIA SRL · Class II
- BRAT 2 — SORIN GROUP ITALIA SRL · Class II
- Global Blood Resources — GLOBAL BLOOD RESOURCES, LLC · Class II
Cleared under the same submission
K960006 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI 90b76747-ab4f-4db4-b584-168ff9139b19 36 fields · synced May 30, 2026