Duns Number:080361159
Device Description: Cushion Face Mask with Eye Tape, Disposable, Adult Medium 1/EA
Catalog Number
-
Brand Name
ASP CUSHION FACE MASK
Version/Model Number
ASPMAT124
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
BSJ
Product Code Name
Mask, Gas, Anesthetic
Public Device Record Key
3db5a38d-bbe1-4da2-9b9b-173d1fa59e58
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 26, 2022
Package DI Number
10840216100883
Quantity per Package
30
Contains DI Package
00840216100886
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |