Duns Number:830016148
Device Description: 3M™ AURA™ Health Care Particulate Respirator and Surgical Mask 1870+Bulk, N95, 440 each/Ca 3M™ AURA™ Health Care Particulate Respirator and Surgical Mask 1870+Bulk, N95, 440 each/Case
Catalog Number
1870+BULK
Brand Name
3M™ Aura™
Version/Model Number
1870+BULK
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
MSH
Product Code Name
Respirator, surgical
Public Device Record Key
7f429e81-536a-4886-9302-16f607a41536
Public Version Date
October 30, 2020
Public Version Number
1
DI Record Publish Date
October 22, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |