Duns Number:830997032
Device Description: N95 Particulate Filter Respirator and Surgical Mask
Catalog Number
-
Brand Name
KIMBERLY-CLARK® FLUIDSHIELD™ PFR95™ Respirator and Surgical Mask
Version/Model Number
46767
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
MSH
Product Code Name
Respirator,surgical
Public Device Record Key
819fbe78-b93a-41db-83d7-366409396bc4
Public Version Date
May 06, 2020
Public Version Number
3
DI Record Publish Date
November 30, 2016
Package DI Number
10036000467670
Quantity per Package
6
Contains DI Package
00036000467673
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |