Duns Number:800056558
Device Description: Infrared Non-Contact Thermometer
Catalog Number
-
Brand Name
"Evenflo® PreciseRead™ Touchless Forehead Thermometer "
Version/Model Number
60321000
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)
Yes
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
4176690b-0515-41ea-ac19-d546968c6177
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 2022
Package DI Number
20032884203226
Quantity per Package
20
Contains DI Package
00032884203222
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton