Duns Number:536137748
Device Description: The Akita Jet Device is a breath actuated jet nebuliser with active flow and volume contro The Akita Jet Device is a breath actuated jet nebuliser with active flow and volume control to ensure precise drug dosing and targeting. It is intended only on conscious, cooperative adults and children with severe asthma. It is designed for temporary oral inhalation of the aerosol created by the device. The system is intended for single patient use.
Catalog Number
01RS0100
Brand Name
AKITA JET
Version/Model Number
AKITA JET Inhalation System
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
K090730
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
700746d9-f0ba-4aee-8625-5aa8e08aae7b
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
June 27, 2017
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. | 8 |