O2-Life™ - O2-Life Oxygen Tubing 25' (7.62m) Crush Resistant - CUTTING EDGE HC BRANDS LLC

Duns Number:080216804

Device Description: O2-Life Oxygen Tubing 25' (7.62m) Crush Resistant Standard Connector

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More Product Details

Catalog Number

RTG-06005

Brand Name

O2-Life™

Version/Model Number

RTG-06005

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

Yes

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

GAZ

Product Code Name

Tubing, Noninvasive

Device Record Status

Public Device Record Key

04cd7bec-6f05-4c5a-b302-1f63c32ac24a

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

October 17, 2016

Additional Identifiers

Package DI Number

10850108006766

Quantity per Package

25

Contains DI Package

00850108006769

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"CUTTING EDGE HC BRANDS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 54