Geratherm

Basic Information

• Brand Name: Geratherm
• Primary DI: 00614801200615
• Version / Model: Clinical Basal Thermometer
• Catalog Number: 20061
• Company Name: R.G. ENTERPRISES (U.S.A.), INC.
• Labeler DUNS: 928998905
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2019-02-21
• Public Version Status: Update
• Public Device Record Key: 0b614661-ffce-449a-85db-585ddc061a11

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

• Single Use: Yes
• 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: No
• 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
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20614801200619	GS1	Bag	25	In Commercial Distribution
Primary	00614801200615	GS1

Customer Contacts

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