AccessGUDID - DEVICE: Geratherm (00614801200615)

GUDID

Device Identifier (DI) Information

Brand Name: Geratherm
Version or Model: Clinical Basal Thermometer
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20061
Company Name: R.G. ENTERPRISES (U.S.A.), INC.

Primary DI Number: 00614801200615
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 928998905 *Terms of Use

Device 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.

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:	Yes
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?
35397	Capillary patient thermometer, mercury	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 mercury (Hg). 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: 0b614661-ffce-449a-85db-585ddc061a11
Public Version Date: February 21, 2019
Public Version Number: 3
DI Record Publish Date: September 01, 2016