Identity
- Trade Name
- Frostmed LITE FDA UDI
- Generic Name
- Laboratory refrigerator/freezer FDA UDI
- Device Name
- Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each, Bluetooth module to communicate with an App FDA UDI
- Model / Reference
- V 1.0 FDA UDI
- Description
- Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each, Bluetooth module to communicate with an App FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003258408 FDA UDI
- FDA Product Code
- KSE FDA UDI
- GMDN Term
- Laboratory 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
Yes
FDA UDI
Category: Laboratory refrigerator/freezer
Frostmed LITE by Frostime Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laboratory refrigerator/freezer.
- Haier — Qingdao Haier Biomedical Co Ltd · Class I
- Haier — Qingdao Haier Biomedical Co Ltd · Class I
- B Medical Systems — B Medical Systems SARL · Class I
- B Medical Systems — B Medical Systems SARL · Class I
- Frostmed PRO — FROSTIME LLC · Class II
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
- Frostime Llc
Sources (1)
- FDA UDI 405dee42-7e07-4595-8ee7-45917e005362 34 fields · synced May 31, 2026