Duns Number:928998905
Device Description: Daisy Infant Pacifier Thermometer is a clinical thermometer intended for the measurement o Daisy Infant Pacifier Thermometer is a clinical thermometer intended for the measurement of oral body temperature in infants and young children. The device is waterproof, uses a CR2032 (3 V) battery. Dimensions: 60 mm x 50 mm x 42 mm. Weight: Approx. 23 grams (including battery). Beeper: Approx. 5 secs. sound signal when end temperature reached. Memory: Built-in memory enabling display of the previously measured value. Shut-off: Automatic shut-off in approx. 30 seconds.Backlight Color Coded Visual fever alarm indicators green yellow and red :36,0 T 37,1 green37,2 T 37,4 yellow37,5 T 43,9 redA protective storage cover included
Catalog Number
30070
Brand Name
Geratherm Daisy Color Pacifier Digital Thermometer
Version/Model Number
RETAIL Baby Pacifier 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
K981456
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
82701603-16e2-4dc4-af48-e3a0c510b09c
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 |