Catalog Number

-

Brand Name

GENTEC®

Version/Model Number

CFM Series

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 21, 2032

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

7a08b16d-68da-4cc8-a1ce-1f72f2c5701e

Public Version Date

April 29, 2022

Public Version Number

1

DI Record Publish Date

April 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-