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ThermaSolutions

FDA UDI

Class II (US FDA UDI)

by Thermasolutions Llc.

Identity

Trade Name
ThermaSolutions FDA UDI
Generic Name
General-purpose patient temperature probe, single-use FDA UDI
Device Name
Temperature probe-pouch with two TMP-1304 FDA UDI
Model / Reference
TMP-1308 FDA UDI
Description
Temperature probe-pouch with two TMP-1304 FDA UDI

Identifiers

Catalog Number
TMP-1308 FDA UDI
Primary DI / UDI-DI
00851450007121 FDA UDI
510(k) Number
K101244 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

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

ThermaSolutions by Thermasolutions Llc. — 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

K101244 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thermasolutions Llc.

Sources (1)

  • FDA UDI ef407d59-ceec-4091-bfaa-fe665098bc2b 36 fields · synced Jun 1, 2026