DRIVEMEDICAL - RespiratoryRespiratory Disposables Product - Drive Devilbiss Healthcare

Duns Number:867673159

Device Description: RespiratoryRespiratory Disposables Product Description: Pediatric Aerosol mask CS/50

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More Product Details

Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

MASK 001P

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

-

Product Code Details

Product Code

BYG

Product Code Name

MASK, OXYGEN

Device Record Status

Public Device Record Key

600dd15a-b9c7-489e-8374-32402745dd8c

Public Version Date

July 01, 2019

Public Version Number

1

DI Record Publish Date

June 21, 2019

Additional Identifiers

Package DI Number

00822383116679

Quantity per Package

50

Contains DI Package

50822383116674

Package Discontinue Date

-

Package Status

In Commercial Distribution

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