Duns Number:039631334
Device Description: The MVD-70, Pocket Neb is an electronic vibrating mesh nebulizer designed to aerosolize li The MVD-70, Pocket Neb is an electronic vibrating mesh nebulizer designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric and adult patients in and out of the home environment.
Catalog Number
-
Brand Name
Pocket Neb
Version/Model Number
MVD-70
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
K142541,K142541
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
b65011a9-065a-48bd-bd39-4343ee118d23
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10856702006010
Quantity per Package
4
Contains DI Package
00856702006013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |