Catalog Number

-

Brand Name

Anesthesia Circuit

Version/Model Number

9391

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

f913635f-d8c3-4817-a1de-99fd92a073aa

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

September 01, 2022

Package DI Number

10709078013864

Quantity per Package

20

Contains DI Package

00709078013867

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case