Duns Number:207372814
Device Description: Fever-Bugz, the kid friendly fever indicator, allows parents to continue monitoring the ch Fever-Bugz, the kid friendly fever indicator, allows parents to continue monitoring the child’s temperature up to 48 hours, easily. The encapsulated liquid crystals technology of Fever-Bugz®, provides user’s body temperature in increases of 2 degrees Fahrenheit, visible in seconds. What’s more, Fever-Bugz can be conveniently placed over armpit, forehead or chest.Accurate within 1 degree Fahrenheit.
Catalog Number
-
Brand Name
Physiologic Fever-Bugz Stick-On Fever Indicators
Version/Model Number
016-720US
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
Yes
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
1a321462-d426-4b6a-99fe-a76c50056413
Public Version Date
August 21, 2020
Public Version Number
5
DI Record Publish Date
January 05, 2017
Package DI Number
05756597263162
Quantity per Package
48
Contains DI Package
05756597262486
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Upper Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |