Duns Number:089569581
Device Description: Prima Pro GentleWare ASTM Level 2 Face Mask, Blue, 3 Ply with Ear Loops, Latex Free, 50 Ma Prima Pro GentleWare ASTM Level 2 Face Mask, Blue, 3 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use
Catalog Number
-
Brand Name
PrimaPro
Version/Model Number
B182028EL
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
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
312f9b8e-a3d5-4890-82cf-706f0dc4b921
Public Version Date
December 31, 2020
Public Version Number
2
DI Record Publish Date
September 18, 2020
Package DI Number
10850022371490
Quantity per Package
10
Contains DI Package
00850022371493
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case