Duns Number:062312574
Device Description: Non Contact Infrared Body Thermometer designed to be used for intermittent measurement and Non Contact Infrared Body Thermometer designed to be used for intermittent measurement and monitoring of human bod temperature by consumers in the home setting and primary care setting as a screening tool.
Catalog Number
-
Brand Name
CVS Pharmacy
Version/Model Number
HTD8813C
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"
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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
a75058b7-9c35-4829-ac1c-0c1eead24a73
Public Version Date
April 30, 2021
Public Version Number
1
DI Record Publish Date
April 22, 2021
Package DI Number
40050428313679
Quantity per Package
48
Contains DI Package
00050428313671
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |