Pocket Neb - Replacement Pocket Neb Nebulizer Medication Cups - MICROVAPOR DEVICES, LLC

Duns Number:039631334

Device Description: Replacement Pocket Neb Nebulizer Medication Cups with Mouthpiece and Mask Adapter

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More Product Details

Catalog Number

-

Brand Name

Pocket Neb

Version/Model Number

MVD-70-8

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

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

eb9b195d-435e-4be4-8501-3713b226a4c2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 26, 2017

Additional Identifiers

Package DI Number

10856702006034

Quantity per Package

4

Contains DI Package

00856702006037

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