Catalog Number

-

Brand Name

ARC Medical

Version/Model Number

6131

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

-

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

K090738,K090738

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

3301d61a-5017-47a9-a14e-78fbe90079f2

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

August 26, 2021

Package DI Number

10810050853863

Quantity per Package

100

Contains DI Package

00810050853866

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case