Oral Temperature Digital Thermometer

FDA UDI

Class II (US FDA UDI)

by Kerma Medical Products, Inc.

Identity

Trade Name: Oral Temperature Digital Thermometer FDA UDI
Generic Name: Intermittent electronic patient thermometer FDA UDI
Device Name: Dual Scale Oral Digital Thermometer with 20 Probe Covers, 60 second read FDA UDI
Model / Reference: 16812 FDA UDI
Description: Dual Scale Oral Digital Thermometer with 20 Probe Covers, 60 second read FDA UDI

Identifiers

Catalog Number: 16812 FDA UDI
Primary DI / UDI-DI: 00612606001529 FDA UDI
510(k) Number: K940686 FDA UDI
FDA Product Code: FLL FDA UDI
GMDN Term: Intermittent electronic patient thermometer 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Intermittent electronic patient thermometer

Oral Temperature Digital Thermometer by Kerma Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Kerma Medical Products, Inc.

Sources (1)

FDA UDI 1d519f82-a514-41c3-8edc-04e336f32d96 35 fields · synced Jun 6, 2026