Catalog Number

900ICON208

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

900ICON208

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

94db914c-b0db-4456-bd60-1b5b19acfa13

Public Version Date

December 11, 2019

Public Version Number

3

DI Record Publish Date

September 10, 2016

Package DI Number

09420012423146

Quantity per Package

60

Contains DI Package

09420012429162

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack