drive - Respiratory Nebs Product Description MEDNEB+ - Drive Devilbiss Healthcare

Duns Number:867673159

Device Description: Respiratory Nebs Product Description MEDNEB+ w/Reusable Neb Cup 1/ea, 8/cv

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More Product Details

Catalog Number

-

Brand Name

drive

Version/Model Number

MQ5700

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 24, 2020

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"

Yes

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

-

Product Code Details

Product Code

CAF

Product Code Name

Nebulizer (direct patient interface)

Device Record Status

Public Device Record Key

5d5a065b-94cb-4de1-b8e6-45f8a4a9c2fb

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

April 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DRIVE DEVILBISS HEALTHCARE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3783
2 A medical device with a moderate to high risk that requires special controls. 832