Catalog Number

DF370-6131Z

Brand Name

UNIVERSAL FLEX2®

Version/Model Number

DF370-6131Z

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

CAI

Product Code Name

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

Public Device Record Key

3d8bd144-2eab-4208-a500-87cb8b617f77

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

April 17, 2019

Package DI Number

00612649213842

Quantity per Package

50

Contains DI Package

00612649213859

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-