Duns Number:081057389
Device Description: FLUIDSHIELD* 3 Ported N95 Particulate Filter Respirator with SAFETY SEAL and SO SOFT* Lini FLUIDSHIELD* 3 Ported N95 Particulate Filter Respirator with SAFETY SEAL and SO SOFT* Lining, Orange, Small Size
Catalog Number
99184
Brand Name
Halyard
Version/Model Number
99184
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
-
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
Product Code
MSH
Product Code Name
Respirator, surgical
Public Device Record Key
09228ebf-f9d9-4091-b2b3-b15f19b9351a
Public Version Date
August 24, 2020
Public Version Number
1
DI Record Publish Date
August 14, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |