Catalog Number

900PT500E

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

900PT500E

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

K131895,K131895

Product Code

BZE

Product Code Name

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

Public Device Record Key

9285ec61-157a-4c1d-a665-ed7a616b9e52

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

September 08, 2016

Package DI Number

09420012427793

Quantity per Package

10

Contains DI Package

09420012424754

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack