Duns Number:828690904
Device Description: Niosh approved N95 respirator, Headband-style, surgical respirator, Electrostatically-char Niosh approved N95 respirator, Headband-style, surgical respirator, Electrostatically-charged filter media provides low breathing resistance, Latex-free, staple-free head straps for comfort and safety, Soft foam nose cushion
Catalog Number
1154801
Brand Name
PureLife N95
Version/Model Number
1154801
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K061375,K061375,K061375
Product Code
MSH
Product Code Name
Respirator, Surgical
Public Device Record Key
eb62ae87-5bd8-4ef3-be32-a6e82dc2a787
Public Version Date
June 22, 2021
Public Version Number
1
DI Record Publish Date
June 14, 2021
Package DI Number
D79011548013
Quantity per Package
240
Contains DI Package
D79011548011
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 | 4 |