Pocket Neb - The MVD-70, Pocket Neb is an electronic vibrating - MICROVAPOR DEVICES, LLC

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

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

Additional Identifiers

Package DI Number

10856702006010

Quantity per Package

4

Contains DI Package

00856702006013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MICROVAPOR DEVICES, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2