Identity
- Trade Name
- PVC Transfer Bag FDA UDI
- Generic Name
- Blood washing/centrifugation bag FDA UDI
- Device Name
- Two 200ml PVC processing bags, with a male luer, a female luer, a needle-free injection port, a spike port, and a CS25 for final freezing of product FDA UDI
- Model / Reference
- 10-200-CS25 FDA UDI
- Description
- Two 200ml PVC processing bags, with a male luer, a female luer, a needle-free injection port, a spike port, and a CS25 for final freezing of product FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10816203023299 FDA UDI
- FDA Product Code
- KSR FDA UDI
- GMDN Term
- Blood washing/centrifugation bag FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9100 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
PVC Transfer Bag by OriGen Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- OriGen Biomedical, Inc.
Sources (1)
- FDA UDI ccb10a5d-ac30-4ef4-9b34-14f88fd33757 35 fields · synced May 30, 2026