DRIVEMEDICAL - RespiratoryRegulators Product Description: Rgltr2 - Drive Devilbiss Healthcare

Duns Number:867673159

Device Description: RespiratoryRegulators Product Description: Rgltr2 Mini870, (111842),0-15L,1ea20cs

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More Product Details

Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

18302GMN-MC2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 2019

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

CAN

Product Code Name

REGULATOR, PRESSURE, GAS CYLINDER

Device Record Status

Public Device Record Key

0b0c9bee-e032-4b05-8a64-44b38058c2f1

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

June 21, 2019

Additional Identifiers

Package DI Number

50822383984884

Quantity per Package

20

Contains DI Package

00822383984889

Package Discontinue Date

June 22, 2019

Package Status

Not 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