Catalog Number

-

Brand Name

DAR

Version/Model Number

R018

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 09, 2021

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

-

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

f1587b06-f3c6-430b-93fd-9f9f3c5c7df1

Public Version Date

April 13, 2021

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

10884522032186

Quantity per Package

10

Contains DI Package

20884522032183

Package Discontinue Date

April 09, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE