Catalog Number

01-06-9580-9

Brand Name

iCOR

Version/Model Number

IPN040596

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

K925622,K925622,K925622

Product Code

BYD

Product Code Name

CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Public Device Record Key

2f10faa0-3c98-4f97-8999-2435309906b1

Public Version Date

September 22, 2020

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

29555342304255

Quantity per Package

15

Contains DI Package

09555342304251

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box