GERATHERM MAGNATHERM MERCURY CLINICAL FREE GLASS THERMOMETER - MagnaTherm Clinical mercury free oral glass - R.G. ENTERPRISES (U.S.A.), INC.

Duns Number:928998905

Device Description: MagnaTherm Clinical mercury free oral glass thermometers is designed with an inner and out MagnaTherm Clinical mercury free oral glass thermometers is 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 under the tongue 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). This thermometer is encased in an optical grade magnifying case with a white retainer allowing the thermometer to slide easily in and out of the case as well as enhancement of the thermometer reading.

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More Product Details

Catalog Number

20041

Brand Name

GERATHERM MAGNATHERM MERCURY CLINICAL FREE GLASS THERMOMETER

Version/Model Number

GLASS ORAL THERMOMETER IN MAGNIFYING CASE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FLK

Product Code Name

Thermometer, Clinical Mercury

Device Record Status

Public Device Record Key

a660d8e3-6bcf-4645-a4c2-f2f662c10c6a

Public Version Date

February 21, 2019

Public Version Number

3

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

20614801200411

Quantity per Package

25

Contains DI Package

00614801200417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag

"R.G. ENTERPRISES (U.S.A.), INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 17