Duns Number:830016148
Device Description: 3M™ ESPE™ Triple Layer Molded Face Mask, 2042F
Catalog Number
2042F
Brand Name
ESPE™
Version/Model Number
2042F
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2022
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
5c166ec7-420d-41fc-97e9-601026b329fa
Public Version Date
September 01, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
50605861032358
Quantity per Package
12
Contains DI Package
30605861032354
Package Discontinue Date
September 01, 2022
Package Status
Not 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 |