Duns Number:830016148
Device Description: 3M™ AURA™ Health Care Particulate Respirator and Surgical Mask Bulk, N95, 440 ea/Case, Res 3M™ AURA™ Health Care Particulate Respirator and Surgical Mask Bulk, N95, 440 ea/Case, Restricted.
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"
-
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
ed6f1a1e-ae8d-4b1d-94b2-ce52de2e6510
Public Version Date
June 10, 2022
Public Version Number
1
DI Record Publish Date
June 02, 2022
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 |