Duns Number:122493866
Device Description: The mesh ultrasonic nebulizer is a device intended to spray liquids in aerosol form into g The mesh ultrasonic nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing.
Catalog Number
A18GBH1098
Brand Name
GBH-MED
Version/Model Number
NB-JLN-MB005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
September 30, 2023
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
K170886
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
29b6a557-3337-4b9b-8648-a501b52ef0a4
Public Version Date
June 27, 2022
Public Version Number
2
DI Record Publish Date
September 08, 2021
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. | 1 |