Geratherm® classic

Basic Information

• Brand Name: Geratherm® classic
• Primary DI: 04018674454681
• Version / Model: GT-1000
• Catalog Number: 4541003568
• Company Name: Geratherm Medical AG
• Labeler DUNS: 328697888
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-06
• Public Version: 1
• Public Version Date: 2023-09-14
• Public Version Status: New
• Public Device Record Key: 2c4c65df-56e2-44ae-a5ec-bb21ce37343a

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLK	Thermometer, Clinical Mercury	General Hospital	880.2920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64142	Capillary patient thermometer, gallium-alloy	An instrument designed to measure a patient's body temperature which is formed as a slender, hollow, sealed tube made of glass with a bulb at one end filled with a non-toxic liquid gallium alloy (typically alloyed with indium and tin). It works on the capillary principle whereby the registered heat proportionally expands the medium, filling a graduated column. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04018674454681	GS1
Package	24018674454685	GS1	Display	24	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]