Inovo - CHAD Regulators - Drive Devilbiss Healthcare

Duns Number:867673159

Device Description: CHAD Regulators

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More Product Details

Catalog Number

-

Brand Name

Inovo

Version/Model Number

CH4808-L-BLUE

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)

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

CAN

Product Code Name

REGULATOR, PRESSURE, GAS CYLINDER

Device Record Status

Public Device Record Key

a75a3362-f97e-418e-81b0-876779621e3f

Public Version Date

October 19, 2021

Public Version Number

3

DI Record Publish Date

February 01, 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