Duns Number:928998905
Device Description: Basal thermometer with magnifying case and pink retainer contains Galinstan, which is a no 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.
Catalog Number
20061
Brand Name
Geratherm
Version/Model Number
Clinical Basal 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
0b614661-ffce-449a-85db-585ddc061a11
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
20614801200619
Quantity per Package
25
Contains DI Package
00614801200615
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 |