Geratherm

FDA UDI

Class II (US FDA UDI)

by R.g. Enterprises (u.s.a.), Inc.

Identity

Trade Name: Geratherm FDA UDI
Generic Name: Capillary patient thermometer, mercury FDA UDI
Device Name: Basal thermometer with magnifying case and pink retainer contains Galinstan, which is a non-toxic, liquid metal that replaces the toxic mercury. The expanded calibration strip provides an accurate temperature display with a magnifying (optical) case for easy temperature reading. It is suitable for oral or axillary temperature monitoring. Easy to clean or disinfect with alcohol or warm soapy water. Temperature measuring range is 97 degrees F to 101 degrees F. FDA UDI
Model / Reference: Clinical Basal Thermometer FDA UDI
Description: Basal thermometer with magnifying case and pink retainer contains Galinstan, which is a non-toxic, liquid metal that replaces the toxic mercury. The expanded calibration strip provides an accurate temperature display with a magnifying (optical) case for easy temperature reading. It is suitable for oral or axillary temperature monitoring. Easy to clean or disinfect with alcohol or warm soapy water. Temperature measuring range is 97 degrees F to 101 degrees F. FDA UDI

Identifiers

Catalog Number: 20061 FDA UDI
Primary DI / UDI-DI: 00614801200615 FDA UDI
FDA Product Code: FLK FDA UDI
GMDN Term: Capillary patient thermometer, mercury FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2920 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Capillary patient thermometer, mercury

Geratherm by R.g. Enterprises (u.s.a.), Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: R.g. Enterprises (u.s.a.), Inc.

Sources (1)

FDA UDI 0b614661-ffce-449a-85db-585ddc061a11 35 fields · synced Jun 1, 2026