Duns Number:543061245
Device Description: Non Woven Face Mask is intended for single use by operating room personnel and other gener Non Woven Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Catalog Number
-
Brand Name
V&Q
Version/Model Number
VQN0185W
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173062,K173062,K173062
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
5648fedd-8a7e-4e2f-916a-1a1700173e49
Public Version Date
July 21, 2021
Public Version Number
3
DI Record Publish Date
October 26, 2020
Package DI Number
16970272170019
Quantity per Package
40
Contains DI Package
06970272170012
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |