Identity
- Trade Name
- SKIN IQ 365 FDA UDI
- Generic Name
- External circulating-air core temperature regulation system pad, reusable FDA UDI
- Device Name
- SKIN IQ 365, COVERLET COMPLETE KIT FDA UDI
- Model / Reference
- SIQCPRUS1UN FDA UDI
- Description
- SKIN IQ 365, COVERLET COMPLETE KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055982783224 FDA UDI
- FDA Product Code
- IOQ FDA UDI
- GMDN Term
- External circulating-air core temperature regulation system pad, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5170 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
Yes
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: External circulating-air core temperature regulation system pad, reusable
Skin Iq 365 by Arjohuntleigh, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External circulating-air core temperature regulation system pad, reusable.
- SKIN IQ 365 — Arjohuntleigh, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Arjohuntleigh, Inc.
Sources (1)
- FDA UDI e44251ba-63d3-4ee7-9c06-cc7db40aa02d 33 fields · synced Jun 6, 2026