Duns Number:006922009
Device Description: Publix Probe Covers
Catalog Number
-
Brand Name
PUBLIX
Version/Model Number
84-329
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
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
41924439-a7e9-45ae-b4d2-7fd9a37045cb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
20041415320738
Quantity per Package
24
Contains DI Package
10041415320731
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 |