Duns Number:831375089
Device Description: Cone Style N95 Mask, Universal, NIOSH
Catalog Number
-
Brand Name
PremierPro
Version/Model Number
2486
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
31aa7eca-37f8-4947-89d4-59029a069163
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
April 28, 2020
Package DI Number
10811220032330
Quantity per Package
12
Contains DI Package
00811220032333
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |