Duns Number:080404727
Device Description: Kinsa QuickCare thermometer. Digital thermometer used to measure body temperature orally, Kinsa QuickCare thermometer. Digital thermometer used to measure body temperature orally, underarm, or rectally.
Catalog Number
-
Brand Name
Kinsa
Version/Model Number
KSA-110
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173730
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
45b3ff00-b6b6-4b82-9dfb-3a7619988a27
Public Version Date
November 01, 2019
Public Version Number
1
DI Record Publish Date
October 24, 2019
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. | 9 |