Resp-O2 Oxygen Regulator CGA 870 Style - Resp-O2 Oxygen Regulator CGA 870 Style, Barb - DYNAREX CORPORATION

Duns Number:008124539

Device Description: Resp-O2 Oxygen Regulator CGA 870 Style, Barb Outlet, Brass-Sleeved, Flow Range: 0-8 LPM

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More Product Details

Catalog Number

-

Brand Name

Resp-O2 Oxygen Regulator CGA 870 Style

Version/Model Number

36351

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

CAN

Product Code Name

Regulator, Pressure, Gas Cylinder

Device Record Status

Public Device Record Key

c454d05f-41cc-4791-abc0-8c105a137f60

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

Additional Identifiers

Package DI Number

00840117309951

Quantity per Package

5

Contains DI Package

00840117309944

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2