AccessGUDID - DEVICE: Geratherm® classic (04018674454681)

GUDID

Device Identifier (DI) Information

Brand Name: Geratherm® classic
Version or Model: GT-1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4541003568
Company Name: Geratherm Medical AG

Primary DI Number: 04018674454681
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 328697888 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLK	Thermometer, Clinical Mercury

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2c4c65df-56e2-44ae-a5ec-bb21ce37343a
Public Version Date: September 14, 2023
Public Version Number: 1
DI Record Publish Date: September 06, 2023