BodyMed - BODYMED DOG PEDIATRIC COMPRESSOR NEBULIZER - BOXOUT, LLC

Duns Number:066689993

Device Description: BODYMED DOG PEDIATRIC COMPRESSOR NEBULIZER SYSTEM, WITH DISPOSIBLE NEBULIZER KIT INCLUDED.

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More Product Details

Catalog Number

-

Brand Name

BodyMed

Version/Model Number

BDMNEBDOG

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"

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

8439b1d3-cc29-4303-a198-66c4c85637d6

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

Additional Identifiers

Package DI Number

20815991024416

Quantity per Package

8

Contains DI Package

00815991024412

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BOXOUT, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 23