Duns Number:830016148
Device Description: 3M™ High Fluid Resistant Surgical Mask with Face Shield 1835FS
Catalog Number
1835FS
Brand Name
3M™
Version/Model Number
1835FS
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
-
Product Code
FXX
Product Code Name
Mask, surgical
Public Device Record Key
a82d5ac8-7286-4ef3-b130-af82ea8b405f
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
50707387562200
Quantity per Package
6
Contains DI Package
30707387562206
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |