Duns Number:942192550
Device Description: Non-woven face mask, with ties, intended for single use by operating room personnel and ot Non-woven face mask, with ties, intended for single use by operating room personnel and other general health care workers to protect patients and healthcare workers against the transfer of microorganisms, blood and body fluids, and particulate materials.
Catalog Number
VQN0185B
Brand Name
PureDefense Surgical Mask
Version/Model Number
VQN0185B
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173062
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
6ca163ca-c10c-4c75-84de-efeddb95dc13
Public Version Date
May 20, 2020
Public Version Number
1
DI Record Publish Date
May 12, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |