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Mon-a-Therm

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Mon-a-Therm FDA UDI
Generic Name
General-purpose patient temperature probe, single-use FDA UDI
Device Name
General Purpose Temperature Probe,400TM FDA UDI
Model / Reference
90050 FDA UDI
Description
General Purpose Temperature Probe,400TM FDA UDI

Identifiers

Primary DI / UDI-DI
20884521031606 FDA UDI
510(k) Number
K874514 FDA UDI
FDA Product Code
FLL FDA UDI
GMDN Term
General-purpose patient temperature probe, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Dimensions & Sizes

Size
Catheter Gauge — 9 French FDA UDI

Category: General-purpose patient temperature probe, single-use

Mon-a-Therm by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K874514 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 5a4710a5-5f3e-4da3-a5f7-b8e9b79f69fd 37 fields · synced May 30, 2026