Duns Number:830016148
Device Description: 3M™ AURA™ Health Care Particulate Respirator and Surgical Mask , N95, 240 ea/Case
Catalog Number
1870+
Brand Name
3M™ Aura™
Version/Model Number
1870+
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)
-
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
b525add8-63fa-4272-8cd3-12db164a76c7
Public Version Date
September 03, 2021
Public Version Number
1
DI Record Publish Date
August 26, 2021
Package DI Number
00638060430941
Quantity per Package
12
Contains DI Package
00638060430958
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 |