Duns Number:830016148
Device Description: 1870+ HEALTH CARE PART RESP. 120/CASE
Catalog Number
1870+
Brand Name
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)
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
2ee7519c-a856-482a-ac36-ef19419430ab
Public Version Date
November 02, 2020
Public Version Number
6
DI Record Publish Date
August 03, 2016
Package DI Number
50051131499961
Quantity per Package
6
Contains DI Package
00051131499966
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 |