Duns Number:544474402
Device Description: Non Contact Infrared Body Thermometer
Catalog Number
-
Brand Name
FIRSTHEALTH
Version/Model Number
HTD8816C
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 10, 2020
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
b8c29b03-8643-4267-8025-3763a5f26059
Public Version Date
April 28, 2021
Public Version Number
3
DI Record Publish Date
October 10, 2020
Package DI Number
16436200289883
Quantity per Package
6
Contains DI Package
06436200289886
Package Discontinue Date
October 10, 2020
Package Status
Not 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 |