Duns Number:830016148
Device Description: 3M™ ESPE™ Molded Face Masks, Rose, 1942FR
Catalog Number
1942FR
Brand Name
ESPE™
Version/Model Number
1942FR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 09, 2025
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
c8da0f7c-117e-4120-81d3-ccbba3cf500e
Public Version Date
March 14, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
50605861032297
Quantity per Package
12
Contains DI Package
30605861032293
Package Discontinue Date
April 09, 2025
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 |