Catalog Number

DFP2110-61

Brand Name

UNIVERSAL FLEX2®BREATHING CIRCUIT

Version/Model Number

DFP2110-61

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

4cba9f3f-1f20-4990-b49a-aa0c0f9f9887

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

00612649168890

Quantity per Package

40

Contains DI Package

00612649202464

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-