Duns Number:008965063
Device Description: Walgreens Forehead Thermometer
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
WIC 256029 /TH1009N
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
K161735,K161735,K161735
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
cb5d1149-a238-4c7c-a305-03b641fb6308
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
September 30, 2020
Package DI Number
20311917221384
Quantity per Package
4
Contains DI Package
00311917221380
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 75 |
2 | A medical device with a moderate to high risk that requires special controls. | 74 |
U | Unclassified | 2 |