Identity
- Trade Name
- K2 Scientific, LLC FDA UDI
- Generic Name
- Blood refrigerator FDA UDI
- Device Name
- 30 Cu. Ft. High-Performance Laboratory Glass Door, Stainless Steel, Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K230GDR-SS-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016. FDA UDI
- Model / Reference
- K230GDRSSBB FDA UDI
- Description
- 30 Cu. Ft. High-Performance Laboratory Glass Door, Stainless Steel, Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K230GDR-SS-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
- K230GDR-SS-BB FDA UDI
- Primary DI / UDI-DI
- G136K230GDRSSBB0 FDA UDI
- FDA Product Code
- KSE FDA UDI
- GMDN Term
- Blood refrigerator 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
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 bb6f1de3-5f83-473a-ae0b-01a0773b8535 35 fields · synced Jun 6, 2026