Catalog Number

RT019

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

RT019

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

K050927,K050927

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

d82b2db0-7b98-4288-be35-aac759397d78

Public Version Date

September 22, 2020

Public Version Number

4

DI Record Publish Date

September 08, 2016

Package DI Number

09420012416452

Quantity per Package

20

Contains DI Package

09420012432315

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack