Catalog Number

-

Brand Name

DAR

Version/Model Number

353S19046

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"

Yes

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

BYD

Product Code Name

CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Public Device Record Key

2e1575a8-7d3e-48b4-81a0-49acab6b3af1

Public Version Date

January 17, 2022

Public Version Number

2

DI Record Publish Date

April 18, 2020

Package DI Number

20884521779379

Quantity per Package

25

Contains DI Package

10884521779372

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE