Identity
- Trade Name
- Cervos Triple Sterility Pack FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- CER-PRP TRIPLE STERILITY PACK PN: 69009-01M FDA UDI
- Model / Reference
- CER-PRP TRIPLE FDA UDI
- Description
- CER-PRP TRIPLE STERILITY PACK PN: 69009-01M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858690006846 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
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
Dimensions & Sizes
- Size
- Total Volume — 120 Milliliter FDA UDI
Category: Haematological concentrate system preparation kit, platelet concentration
Cervos Triple Sterility Pack by Ranfac Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BK200543 also covers:
- CER-PRP-JUVA — RANFAC CORP.
- CER-PRP-JUVA-KIT — RANFAC CORP.
- Cervos Platelet Separator Double Pack — RANFAC CORP.
- Cervos Platelet Separator Double Pack — RANFAC CORP.
- Cervos Platelet Separator Double Pack with Blood Draw — RANFAC CORP.
- Cervos Platelet Separator Double Pack with Blood Draw and ACD-A — RANFAC CORP.
- Cervos Platelet Separator Single 5 Pack — RANFAC CORP.
- Cervos Platelet Separator Single Pack — RANFAC CORP.
- Cervos Platelet Separator Single Pack — RANFAC CORP.
- Cervos Platelet Separator Single Pack with Blood Draw — RANFAC CORP.
- Cervos Platelet Separator Triple Pack — RANFAC CORP.
- Cervos Platelet Separator Triple Pack — RANFAC CORP.
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
- Ranfac Corp.
Sources (1)
- FDA UDI 5315b82e-d3ed-4124-8e42-66c83ea09963 37 fields · synced May 30, 2026