Duns Number:006922009
Device Description: 9 Second Flexible Thermometer
Catalog Number
-
Brand Name
PUBLIX
Version/Model Number
84-359
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K041516,K041516,K041516
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
75bd38ab-985f-4bb0-968b-af36cd53a615
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20041415319732
Quantity per Package
144
Contains DI Package
10041415319735
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
MASTER CARTON
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 17 |