Catalog Number

-

Brand Name

Disposable Breathing Circuits

Version/Model Number

5703

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

f376f791-7a6f-4e59-8016-567ec193ce58

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

September 30, 2020

Package DI Number

10709078011495

Quantity per Package

10

Contains DI Package

00709078011498

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-