Duns Number:081057389
Device Description: HALYARD* Pink Level 1 Procedure Mask with Earloops
Catalog Number
57578
Brand Name
Halyard
Version/Model Number
57578
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
FXX
Product Code Name
Mask, surgical
Public Device Record Key
02adb807-9109-4e9d-a1b2-c7ed4ef65cd2
Public Version Date
July 29, 2022
Public Version Number
1
DI Record Publish Date
July 21, 2022
Package DI Number
30680651575785
Quantity per Package
10
Contains DI Package
20680651575788
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| 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 |