Duns Number:928998905
Device Description: The ColorChoice Rectal Digital non-flex tip thermometer is white with red accent colors ar The ColorChoice Rectal Digital non-flex tip thermometer is white with red accent colors around the display window and start button. The temperature measuring range is 90.0°F to 109.0°F. It uses a 1.55V battery with more than 200 hours of continuous use. An audible beep sounds with the peak temperature is reached and the Memory Mode displays the last reading. A battery replacement symbol will appear on the display when the battery is low with an auto shut off feature in 10 minutes. A clear protective case is provided.
Catalog Number
30051
Brand Name
Geratherm Colorchoice Rectal Digital Thermometer
Version/Model Number
Rectal Digital Thermometer with red and white colors
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,K903590
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
68838a3e-2ca3-4fcc-946b-3f6c48c67149
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
20614801300517
Quantity per Package
25
Contains DI Package
00614801300513
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 |