Duns Number:928998905
Device Description: Hypothyroid Basal thermometer with magnifying case and blue retainer contains Galinstan, w Hypothyroid Basal thermometer with magnifying case and blue 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.
Catalog Number
40070
Brand Name
GERATHERM MERCURY FREE GLASS HYPOTHYROID THERMOMETER
Version/Model Number
GLASS HYPOTHYROID BASAL THERMOMETER WITH BLUE COLOR STRIP
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
a1c3b0a5-7eb3-4695-a2b3-d9eff540b33b
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
60614801400703
Quantity per Package
6
Contains DI Package
00614801400701
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |