Identity
- Trade Name
- Geratherm® classic FDA UDI
- Generic Name
- Capillary patient thermometer, gallium-alloy FDA UDI
- Device Name
- The Geratherm® classic is a clinical glass thermometer without mercury for rectal, oral and axillary measurement of body temperature. The thermometer is designed with an inner and outer barrel of glass. The inner barrel contains Galinstan a non-toxic liquid metal-alloy comprised of Gallium, Indium and Tin. It measures body temperature in both Celsius and Fahrenheit. When heat is applied, such as placing the tip of the thermometer in the rectum the Galinstan rises up the column until the maximum temperature is achieved. The temperature measuring range is from 95° F (35.5°C) to 108°F (42°C). A storage case and reset tool is provided. FDA UDI
- Model / Reference
- GT-1000 FDA UDI
- Description
- The Geratherm® classic is a clinical glass thermometer without mercury for rectal, oral and axillary measurement of body temperature. The thermometer is designed with an inner and outer barrel of glass. The inner barrel contains Galinstan a non-toxic liquid metal-alloy comprised of Gallium, Indium and Tin. It measures body temperature in both Celsius and Fahrenheit. When heat is applied, such as placing the tip of the thermometer in the rectum the Galinstan rises up the column until the maximum temperature is achieved. The temperature measuring range is from 95° F (35.5°C) to 108°F (42°C). A storage case and reset tool is provided. FDA UDI
Identifiers
- Catalog Number
- 4541003568 FDA UDI
- Primary DI / UDI-DI
- 04018674454681 FDA UDI
- FDA Product Code
- FLK FDA UDI
- GMDN Term
- Capillary patient thermometer, gallium-alloy 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Category: Capillary patient thermometer, gallium-alloy
Geratherm® classic by Geratherm Medical AG — 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
- Geratherm Medical AG
Sources (1)
- FDA UDI 2c4c65df-56e2-44ae-a5ec-bb21ce37343a 35 fields · synced May 31, 2026