Catalog Number

-

Brand Name

DAR

Version/Model Number

351U5410

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

04463c76-f7f7-419d-a436-3ee2bb64e3a5

Public Version Date

January 11, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10884522032285

Quantity per Package

50

Contains DI Package

20884522032282

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE