Catalog Number

900ICON203

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

900ICON203

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OUG

Product Code Name

Medical Device Data System

Public Device Record Key

ee17602d-22cf-4669-9dda-72040c839b04

Public Version Date

August 10, 2022

Public Version Number

1

DI Record Publish Date

August 02, 2022

Package DI Number

09420012429100

Quantity per Package

5

Contains DI Package

09420012424266

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK