Duns Number:056332380
Catalog Number
-
Brand Name
AeroGear™
Version/Model Number
Asthma Action Kit, cs/10
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"
-
For Single-Use
-
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
-
Product Code Name
-
Public Device Record Key
63b7fa3a-a01f-4812-9217-fc1bcf40dffe
Public Version Date
September 09, 2021
Public Version Number
3
DI Record Publish Date
December 19, 2016
Package DI Number
50604351895107
Quantity per Package
10
Contains DI Package
00604351895102
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 | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 39 |