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Tecotherm

FDA UDI

Class I (US FDA UDI)

by Inspiration Healthcare, Ltd.

Identity

Trade Name
Tecotherm FDA UDI
Generic Name
General-purpose patient temperature probe, single-use FDA UDI
Device Name
TC989803162601 Adaptor cable for Philips disposable rectal probes FDA UDI
Model / Reference
TC989803162601 FDA UDI
Description
TC989803162601 Adaptor cable for Philips disposable rectal probes FDA UDI

Identifiers

Primary DI / UDI-DI
05060206921849 FDA UDI
FDA Product Code
ISN FDA UDI
GMDN Term
General-purpose patient temperature probe, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3420 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: General-purpose patient temperature probe, single-use

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

Similar devices

Also classified as General-purpose patient temperature probe, single-use.

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 ff24a06b-70c0-4f8d-a994-d3875227a09f 34 fields · synced May 30, 2026