Catalog Number

-

Brand Name

Disposable Anesthesia Circuits

Version/Model Number

9357

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

K922492,K922492

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

bf1c5824-30bd-4d33-a309-1170821e74a3

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

August 31, 2020

Package DI Number

10709078009157

Quantity per Package

20

Contains DI Package

00709078009150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-