Catalog Number

R028

Brand Name

DAR

Version/Model Number

R028

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 17, 2019

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

135c1ffa-c4bf-4d72-bb80-5f653505ce2a

Public Version Date

September 22, 2020

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10884522032292

Quantity per Package

10

Contains DI Package

20884522032299

Package Discontinue Date

September 17, 2019

Package Status

Not in Commercial Distribution

Package Type

CASE