Identity
- Trade Name
- PrepaCyte-CB 500 FDA UDI
- Generic Name
- Blood centrifugation system containment kit FDA UDI
- Device Name
- The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total nucleated cells (TNC) from human umbilical cord blood FDA UDI
- Model / Reference
- PCB500 FDA UDI
- Description
- The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total nucleated cells (TNC) from human umbilical cord blood FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861880000333 FDA UDI
- FDA Product Code
- OAO FDA UDI
- GMDN Term
- Blood centrifugation system containment kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9900 FDA UDI
- Commercial Distribution
- 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
Yes
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
Yes
FDA UDI
Category: Blood centrifugation system containment kit
PrepaCyte-CB 500 by Cryo-Cell International, Inc. — 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
- Cryo-Cell International, Inc.
Sources (1)
- FDA UDI 266e14c0-2ba2-4d2c-88a2-05f1d8034f73 35 fields · synced May 31, 2026