Catalog Number

RT232

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

RT232

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

-

Product Code

BZE

Product Code Name

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Public Device Record Key

7430f7ad-74d0-4347-a345-dcee10beb5eb

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

August 02, 2022

Package DI Number

09420012456717

Quantity per Package

10

Contains DI Package

09420012456601

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK