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WarmTouch

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
WarmTouch FDA UDI
Generic Name
External circulating-air core temperature regulation system pad, single-use FDA UDI
Device Name
Pediatric Surgical Blanket FDA UDI
Model / Reference
5030850 FDA UDI
Description
Pediatric Surgical Blanket FDA UDI

Identifiers

Primary DI / UDI-DI
20884521061511 FDA UDI
510(k) Number
K913016 FDA UDI
FDA Product Code
DWJ 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
870.5900 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: External circulating-air core temperature regulation system pad, single-use

WarmTouch by Covidien LP — 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.

Cleared under the same submission

K913016 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 6a852b36-4c61-4a2a-a297-f5f064e20552 35 fields · synced Jun 8, 2026