Catalog Number

AA001JS

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

AA001JS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K201723,K201723

Product Code

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

0d09e0ea-3258-4139-83ec-98f6e691c4f6

Public Version Date

June 09, 2022

Public Version Number

1

DI Record Publish Date

June 01, 2022

Package DI Number

09420012470997

Quantity per Package

10

Contains DI Package

09420012470980

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK