Duns Number:081057389
Device Description: FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and SO FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and SO SOFT* Lining, Orange, Regular Size
Catalog Number
76767
Brand Name
Halyard
Version/Model Number
76767
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
K974068,K974068,K974068
Product Code
MSH
Product Code Name
Respirator, surgical
Public Device Record Key
85968dca-fecf-49e5-856f-199caa72fb7b
Public Version Date
November 26, 2020
Public Version Number
1
DI Record Publish Date
November 18, 2020
Package DI Number
30680651767678
Quantity per Package
9
Contains DI Package
20680651767671
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1044 |