Duns Number:141668116
Device Description: The device is a Vibrating Mesh Nebulizer System that designed to aerosolize liquid medicat The device is a Vibrating Mesh Nebulizer System that designed to aerosolize liquid medication for inhalation therapy by the patient.
Catalog Number
-
Brand Name
Sunset Handheld Mesh Nebulizer
Version/Model Number
NEB402
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
K182906,K182906
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
0ff900f7-bc06-483f-88ec-23f840bf8078
Public Version Date
September 23, 2022
Public Version Number
1
DI Record Publish Date
September 15, 2022
Package DI Number
10848530098534
Quantity per Package
30
Contains DI Package
00848530098537
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 160 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 68 |