Duns Number:059247507
Device Description: Disposable Forehead Thermometer.
Catalog Number
PDF200-01
Brand Name
Meijer
Version/Model Number
Adult Disposable Forehead Thermometer
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"
Yes
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
KPD
Product Code Name
Strip, Temperature, Forehead, Liquid Crystal
Public Device Record Key
66ad0fe8-00cd-4ea7-b6fc-2aa6147f9fc3
Public Version Date
February 24, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
40815236020597
Quantity per Package
1440
Contains DI Package
30815236020590
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 39 |