Catalog Number

-

Brand Name

DAR

Version/Model Number

352/5805TC

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

bb5339bb-6f67-4dec-a6d3-f61040863b58

Public Version Date

November 11, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10884522035118

Quantity per Package

25

Contains DI Package

20884522035115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE