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Tecotherm

FDA UDI

Class I (US FDA UDI)

by Inspiration Healthcare, Ltd.

Identity

Trade Name
Tecotherm FDA UDI
Generic Name
External circulating-fluid core temperature regulation system pad, reusable FDA UDI
Device Name
TC-MATT-NEO Reusable Aqua Wrap FDA UDI
Model / Reference
TC-MATT-NEO FDA UDI
Description
TC-MATT-NEO Reusable Aqua Wrap FDA UDI

Identifiers

Primary DI / UDI-DI
05060206921771 FDA UDI
FDA Product Code
FOH FDA UDI
GMDN Term
External circulating-fluid core temperature regulation system pad, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: External circulating-fluid core temperature regulation system pad, reusable

Tecotherm by Inspiration Healthcare, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External circulating-fluid core temperature regulation system pad, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inspiration Healthcare, Ltd.

Sources (1)

  • FDA UDI 03deecd7-e2f2-436c-a861-d1635d69f0d6 34 fields · synced May 30, 2026