Duns Number:928998905
Device Description: SolarTherm Speed digital flex tip thermometer is white with blue accent colors and is used SolarTherm Speed digital flex tip thermometer is white with blue accent colors and is used to measure body temperatures orally, rectally or axillary. The temperature measuring range is from 89.6°~111.0°F. If the reading is below 89.6°F, the letter L will be displayed indicating Low reading. If the reading is above 111.0°F, the letter H will be displayed indicating High reading. Energy is supplied using an integrated solar cell with approximately 25 temperature readings within 60-minutes before a recharge is needed. There is an audible beeping for 8 seconds after peak temperature is reached, built-in memory recall enabling display of the previously measured and automatic shut-off in about 9 minutes. Prior to using the solar cell must be exposed to a light source at least 3 hours. This may be in room light or sunlight. A half circle symbol will appear in the display when the solar cell needs to be recharged. Turn the power off before recharging, the solar cell should face the light source during recharging and for ongoing use store on counter top where thermometer is exposed to light throughout the day. A clear plastic cover is provided.
Catalog Number
40053
Brand Name
Geratherm SolarTherm Speed Digital Thermometer
Version/Model Number
Retail SolarTherm Digital Thermomete
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
K903590
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
590edd0b-b422-4985-b9cb-e31f5baee8af
Public Version Date
July 06, 2018
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 |