GERATHERM MERCURY FREE GLASS THERMOMETER

Basic Information

• Brand Name: GERATHERM MERCURY FREE GLASS THERMOMETER
• Primary DI: 00614801200516
• Version / Model: RECTAL THERMOMETER
• Catalog Number: 20051
• 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: cf8226d4-4573-4d2a-9c6b-c5c7f8c1827a

Device Description

The Geratherm mercury free rectal glass thermometers are designed with an inner and outer barrel of glass. The inner barrel contains Galinstan a non-toxic liquid metal comprised of Gallium, Indium and Tin. It measures body temperature in both Celsius and Fahrenheit, and functions like the standard mercury thermometer. 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...normally in 3 minutes. The temperature measuring range is from 95° F (35.5°C) to 108°F (42°C). The fluted tip of the thermometer prevents over insertion. A protective plastic case with a red top is provided.

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	20614801200510	GS1	Bag	25	In Commercial Distribution
Primary	00614801200516	GS1

Customer Contacts

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