Catalog Number

-

Brand Name

Star Lumen Oxygen Tubing 7ft with One Standard and One Wide Connector

Version/Model Number

032-10-063U

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Public Device Record Key

b95cdcd9-388f-4893-af84-7a3b2f292fce

Public Version Date

February 05, 2020

Public Version Number

1

DI Record Publish Date

January 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-