Duns Number:928998905
Device Description: The Geratherm mercury free oral glass thermometers are designed with an inner and outer ba The Geratherm mercury free oral 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 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). A protective plastic case with a green cap is provided.
Catalog Number
20030
Brand Name
GERATHERM MERCURY FREE GLASS ORAL THERMOMETER
Version/Model Number
RETAIL GLASS ORAL THERMOMETER
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
FLK
Product Code Name
Thermometer, Clinical Mercury
Public Device Record Key
aa5d6770-005d-4cb2-a025-5b59836d0fb7
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |