Catalog Number

MYOPT9MEDIUM

Brand Name

Fisher and Paykel Healthcare

Version/Model Number

MYOPT9MEDIUM

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

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

737bb52d-db74-4bf7-8219-282ac0fc222d

Public Version Date

August 10, 2022

Public Version Number

1

DI Record Publish Date

August 02, 2022

Package DI Number

09420012469670

Quantity per Package

10

Contains DI Package

09420012469687

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK