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WarmTouch

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
WarmTouch FDA UDI
Generic Name
Circulating-air whole-body heating system control unit FDA UDI
Device Name
Convective Warming Unit Refurbished FDA UDI
Model / Reference
5016000-RFB FDA UDI
Description
Convective Warming Unit Refurbished FDA UDI

Identifiers

Primary DI / UDI-DI
10884521169227 FDA UDI
510(k) Number
K123083 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
Circulating-air whole-body heating system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5900 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

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Circulating-air whole-body heating system control unit

WarmTouch by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-air whole-body heating system control unit.

Cleared under the same submission

K123083 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 7f6aeb8c-981e-467f-8542-68b3c72f1147 36 fields · synced Jun 1, 2026