Duns Number:830016148
Device Description: 1860S HEALTH CARE RESPIRATOR N95 120EA/C
Catalog Number
1860S
Brand Name
3M™
Version/Model Number
1860S
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
K955382,K955382,K955382
Product Code
FXX
Product Code Name
Mask, surgical
Public Device Record Key
acbb0d42-269d-4ce0-a14f-48ae119f1600
Public Version Date
June 19, 2020
Public Version Number
5
DI Record Publish Date
August 03, 2016
Package DI Number
58887719257409
Quantity per Package
6
Contains DI Package
08887719257404
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 |