Duns Number:092673953
Device Description: Face Mask,Small Adult W/Hook Ring,No Valve, Series 800
Catalog Number
-
Brand Name
Face Mask,Small Adult
Version/Model Number
7-9802
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BSJ
Product Code Name
Mask, Gas, Anesthetic
Public Device Record Key
83da616d-65b9-4037-8187-7d1d5f498b7a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 19, 2017
Package DI Number
10709078003643
Quantity per Package
20
Contains DI Package
00709078003646
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |