Duns Number:092673953
Device Description: Aerosol Mask, Pediatric Elongated, Single Vents
Catalog Number
-
Brand Name
Aerosol Masks
Version/Model Number
220-E
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
BYG
Product Code Name
Mask, Oxygen
Public Device Record Key
bf871c42-d1bb-447b-840b-69da7f2bc0b9
Public Version Date
June 08, 2021
Public Version Number
1
DI Record Publish Date
May 31, 2021
Package DI Number
10709078012447
Quantity per Package
50
Contains DI Package
00709078012440
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 |