Identity
- Trade Name
- ProGen PC Kit FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer. FDA UDI
- Model / Reference
- BELL-82380-A FDA UDI
- Description
- The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer. FDA UDI
Identifiers
- Catalog Number
- BELL-82380-A FDA UDI
- Primary DI / UDI-DI
- 00861122000312 FDA UDI
- FDA Product Code
- ORG FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 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
Ethylene Oxide FDA UDI
Category: Haematological concentrate system preparation kit, platelet concentration
ProGen PC Kit by Cellmedix Holdings, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haematological concentrate system preparation kit, platelet concentration.
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Cleared under the same submission
BK130079 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
- Cellmedix Holdings, Llc
Sources (1)
- FDA UDI 7f0c59c8-cd07-4cea-afd5-d19df00403d2 35 fields · synced Jun 8, 2026