Catalog Number

-

Brand Name

Omni-Link/Flex-Link

Version/Model Number

10-55363

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"

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Public Device Record Key

4f6e84db-3ce0-4ad0-9621-15e494181ea6

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

August 31, 2018

Package DI Number

30641043553637

Quantity per Package

50

Contains DI Package

10641043553633

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-