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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-MRK Mattress Repair Kit FDA UDI
Model / Reference
TC-MRK FDA UDI
Description
TC-MRK Mattress Repair Kit FDA UDI

Identifiers

Primary DI / UDI-DI
05060206921818 FDA UDI
FDA Product Code
KGX FDA UDI
GMDN Term
External circulating-fluid core temperature regulation system pad, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5240 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 375796d4-40ef-4a79-b89c-0192d3461e6e 34 fields · synced Jun 1, 2026