Duns Number:989510003
Device Description: Aerogen Pro Elbow Facemask
Catalog Number
-
Brand Name
Aerogen® Professional Nebulizer System
Version/Model Number
10-061
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K021175
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
e6966772-bef4-43e7-b1a6-462f342aa6ca
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 120 |