Catalog Number

-

Brand Name

DAR

Version/Model Number

350/5879

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"

-

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

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Public Device Record Key

5ccedd24-cc84-402f-b7c0-e9116adce057

Public Version Date

July 01, 2021

Public Version Number

3

DI Record Publish Date

July 17, 2020

Package DI Number

10884521719477

Quantity per Package

1

Contains DI Package

20884521719474

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE