Duns Number:815240958
Device Description: Medical Face Mask - Ties, Duckbill, Green, 80mm Hg ASTM Level 1
Catalog Number
-
Brand Name
VIVIT
Version/Model Number
10333TM
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"
Yes
For Single-Use
Yes
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
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
ba35c291-02b7-49bc-b86a-fedeae1dc22e
Public Version Date
November 08, 2021
Public Version Number
1
DI Record Publish Date
October 30, 2021
Package DI Number
20810084210103
Quantity per Package
6
Contains DI Package
10810084210106
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case