Identity
- Trade Name
- Boekel Small Platelet Incubator FDA UDI
- Generic Name
- Platelet incubator FDA UDI
- Model / Reference
- 301550 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863626000232 FDA UDI
- FDA Product Code
- KSH FDA UDI
- GMDN Term
- Platelet incubator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9575 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Platelet incubator
Boekel Small Platelet Incubator by Boekel Industries, 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
- Boekel Industries, Inc.
Sources (1)
- FDA UDI e576cc19-8342-49e1-8006-8905f526b10c 33 fields · synced May 31, 2026