Duns Number:544474402
Device Description: Non Contact Infrared Body Thermometer
Catalog Number
-
Brand Name
Joyhicare
Version/Model Number
HTD8816C
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
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
d86156c9-f995-4189-92ec-067f29748361
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 11, 2021
Package DI Number
16970289035424
Quantity per Package
100
Contains DI Package
06970289035427
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 53 |