Duns Number:051957769
Device Description: Fever Thermometer
Catalog Number
-
Brand Name
Reli On
Version/Model Number
06429
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
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
3ea3bd7f-6a7e-4070-8175-b88f1fa39435
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 29, 2016
Package DI Number
26811310642938
Quantity per Package
3
Contains DI Package
00681131064293
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 76 |