Catalog Number

AF4110-6121Z

Brand Name

UNIVERSAL F® FLEX2®

Version/Model Number

AF4110-6121Z

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

CAI

Product Code Name

Circuit, breathing (w connector, adaptor, y piece)

Public Device Record Key

10feae50-37f7-46f9-8ef0-e62feeabaac0

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

June 23, 2022

Package DI Number

00612649215877

Quantity per Package

30

Contains DI Package

00612649215884

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-