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Skin Iq

FDA UDI

Class II (US FDA UDI)

by Arjohuntleigh, Inc.

Identity

Trade Name
SKIN IQ FDA UDI
Generic Name
External circulating-air core temperature regulation system pad, single-use FDA UDI
Device Name
Skin IQ Microclimate Manager - Mattress Coverlet and power supply - Complete Kit, 4 Pack FDA UDI
Model / Reference
SIQCPST04US FDA UDI
Description
Skin IQ Microclimate Manager - Mattress Coverlet and power supply - Complete Kit, 4 Pack FDA UDI

Identifiers

Primary DI / UDI-DI
05055982783125 FDA UDI
FDA Product Code
IOQ FDA UDI
GMDN Term
External circulating-air core temperature regulation system pad, single-use 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

Yes

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, single-use

Skin Iq 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, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arjohuntleigh, Inc.

Sources (1)

  • FDA UDI 66c9d02b-9618-4e8b-83b1-07e839b6fada 33 fields · synced May 31, 2026