Duns Number:926820705
Device Description: The N95 Respirator is designed to help provide respiratory protection for the user. This p The N95 Respirator is designed to help provide respiratory protection for the user. This product has a filter efficiency of 95% or greater against solid and liquid aerosols free of oil. This product contains no components made from natural rubber latex.
Catalog Number
-
Brand Name
A&Z Pharmaceutical
Version/Model Number
M8004
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MSH
Product Code Name
Respirator, Surgical
Public Device Record Key
2053579c-4d7b-47f2-9c53-7b5a3423a774
Public Version Date
November 04, 2021
Public Version Number
1
DI Record Publish Date
October 27, 2021
Package DI Number
00850024750272
Quantity per Package
20
Contains DI Package
00850024750081
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton