Identity
- Trade Name
- PrepaCyte-CB 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, prior to banking. The device is composed of two integrally-attached processing and storage containers (or a single processing container) with separation media. FDA UDI
- Model / Reference
- PCB2100-270 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, prior to banking. The device is composed of two integrally-attached processing and storage containers (or a single processing container) with separation media. FDA UDI
Identifiers
- Catalog Number
- P/N PCB2100-270 FDA UDI
- Primary DI / UDI-DI
- 00861880000326 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
No
FDA UDI
Dimensions & Sizes
- Size
- Depth — 0.74 Centimeter FDA UDILength — 8.84 Centimeter FDA UDIWidth — 7.04 Centimeter FDA UDI
Category: Blood centrifugation system containment kit
PrepaCyte-CB 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 9f63526d-551f-4c38-9c7f-b16231ee918e 37 fields · synced May 30, 2026