Catalog Number

F94580

Brand Name

UNIVERSAL FLEX2®BREATHING CIRCUIT & PACK KIT

Version/Model Number

F94580

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 09, 2021

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

727e79df-26ad-4048-93b4-0e3a736c47d5

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

September 22, 2016

Package DI Number

00612649176871

Quantity per Package

40

Contains DI Package

00612649203324

Package Discontinue Date

April 09, 2021

Package Status

Not in Commercial Distribution

Package Type

-