Duns Number:656002163
Device Description: The WowGoHealth IR Ear Thermometer with Bluetooth (Model GSH-BTS301) is an infrared thermo The WowGoHealth IR Ear Thermometer with Bluetooth (Model GSH-BTS301) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
Catalog Number
-
Brand Name
WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301
Version/Model Number
GSH-BTS301
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
K110559,K110559
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
5c1b1fee-4ed8-4959-b6a6-28802963cd8c
Public Version Date
July 22, 2019
Public Version Number
1
DI Record Publish Date
July 12, 2019
Package DI Number
54719878123018
Quantity per Package
40
Contains DI Package
04719878123013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |