Identity
- Trade Name
- George King Coumadin® Plasma Convenience Kit FDA UDI
- Generic Name
- Prothrombin time (PT) IVD, control FDA UDI
- Device Name
- The George King Coumadin® Plasma Kit is a convenience control kit that contains citrated human fresh frozen plasma from donors on Coumadin® therapy. Each kit contains control material with six different INR levels. FDA UDI
- Model / Reference
- 0090-30 FDA UDI
- Description
- The George King Coumadin® Plasma Kit is a convenience control kit that contains citrated human fresh frozen plasma from donors on Coumadin® therapy. Each kit contains control material with six different INR levels. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815696021099 FDA UDI
- FDA Product Code
- GGN FDA UDI
- GMDN Term
- Prothrombin time (PT) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
George King Coumadin® Plasma Convenience Kit by George King Bio-Medical, 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
- George King Bio-Medical, Inc.
Sources (1)
- FDA UDI 30631cd2-1023-4562-b122-013527d5b15c 36 fields · synced Jun 8, 2026