Identity
- Trade Name
- K2 Scientific, LLC FDA UDI
- Generic Name
- Blood refrigerator/freezer FDA UDI
- Device Name
- 25 Cu. Ft. High-Performance Laboratory, Solid Door, Blood Bank Freezer. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of -25°C with a standard temperature range of -10°C to -30°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225SDF-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016. FDA UDI
- Model / Reference
- K225SDFBB FDA UDI
- Description
- 25 Cu. Ft. High-Performance Laboratory, Solid Door, Blood Bank Freezer. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of -25°C with a standard temperature range of -10°C to -30°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225SDF-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016. FDA UDI
Identifiers
- Catalog Number
- K225SDF-BB FDA UDI
- Primary DI / UDI-DI
- G136K225SDFBB0 FDA UDI
- FDA Product Code
- KSE FDA UDI
- GMDN Term
- Blood refrigerator/freezer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9700 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: Blood refrigerator/freezer
K2 Scientific, LLC by K2 Scientific, LLC — 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
- K2 Scientific, LLC
Sources (1)
- FDA UDI 383271bf-4223-4dda-905b-a7d497c57fca 35 fields · synced May 30, 2026