Catalog Number

AA001S

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

AA001S

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"

Yes

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

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

b51f3da1-a9cb-44e8-b7ae-be62a63f1d78

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

September 08, 2016

Package DI Number

09420012435569

Quantity per Package

10

Contains DI Package

09420012435576

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack