Catalog Number

-

Brand Name

DAR

Version/Model Number

351U5856

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

3c36f7b3-2bd6-4f83-adc5-99c3dbfcc779

Public Version Date

January 17, 2022

Public Version Number

3

DI Record Publish Date

May 02, 2019

Package DI Number

20884521747767

Quantity per Package

50

Contains DI Package

10884521747760

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE