Identity
- Trade Name
- CompoMat G5 FDA UDI
- Generic Name
- Blood component separator, automated FDA UDI
- Device Name
- The CompoMat G5 / CompoMaster Net G5 System is intended as an automated blood component separator used for blood component separation and preparation. The CompoMat G5 can carry out almost all preparation methods and handle almost all blood bag systems, such as conventional double, triple and quadruple blood bag systems. FDA UDI
- Model / Reference
- 9025561 FDA UDI
- Description
- The CompoMat G5 / CompoMaster Net G5 System is intended as an automated blood component separator used for blood component separation and preparation. The CompoMat G5 can carry out almost all preparation methods and handle almost all blood bag systems, such as conventional double, triple and quadruple blood bag systems. FDA UDI
Identifiers
- Catalog Number
- 9025561 FDA UDI
- Primary DI / UDI-DI
- 04086000860475 FDA UDI
- FDA Product Code
- KSS FDA UDI
- GMDN Term
- Blood component separator, automated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9050 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: Blood component separator, automated
CompoMat G5 by Fresenius Kabi — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BK110012 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 I | Pending data |
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Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI 32e1dad2-6fae-491b-a83a-2c6d08b39fc9 36 fields · synced May 30, 2026