Catalog Number

01-06-3180-8

Brand Name

iCOR

Version/Model Number

IPN040503

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

K900150,K900150,K900150

Product Code

BYD

Product Code Name

CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Public Device Record Key

3d02e34e-d200-4ba7-96ab-4159ff7266f1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

49555342303986

Quantity per Package

24

Contains DI Package

29555342303982

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case