Duns Number:007914906
Device Description: A device designed to measure skin temperature at several different points using liquid-cry A device designed to measure skin temperature at several different points using liquid-crystal sensors that are sealed in a plastic band applied to the forehead. The device may be used in the home. This is a reusable device.
Catalog Number
-
Brand Name
Good Neighbor Pharmacy
Version/Model Number
700
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
KPD
Product Code Name
Strip, Temperature, Forehead, Liquid Crystal
Public Device Record Key
bb8527a1-dc4a-4342-9ef5-a7fee84b50aa
Public Version Date
August 08, 2022
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
10087701565868
Quantity per Package
24
Contains DI Package
20087701565865
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |