Identity
- Trade Name
- Soft-Temp FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
- Device Name
- Blanket Pediatric 24x30in (Filled Dimensions) Hyper-Hypothermia Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free disposable. FDA UDI
- Model / Reference
- ST-230 FDA UDI
- Description
- Blanket Pediatric 24x30in (Filled Dimensions) Hyper-Hypothermia Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free disposable. FDA UDI
Identifiers
- Catalog Number
- ST-230 FDA UDI
- Primary DI / UDI-DI
- 10615089123006 FDA UDI
- FDA Product Code
- ILO FDA UDI
- GMDN Term
- Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5720 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Soft-Temp by Adroit Medical Systems, 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
- Adroit Medical Systems, Inc.
Sources (1)
- FDA UDI 7f45acf2-2f5d-4e68-8991-4b21b573f19c 36 fields · synced Jun 9, 2026