Catalog Number

OPT318

Brand Name

Fisher and Paykel Healthcare

Version/Model Number

OPT318

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

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

b3f8ad3c-cbaf-4276-b17e-366c4a4848d6

Public Version Date

August 10, 2022

Public Version Number

1

DI Record Publish Date

August 02, 2022

Package DI Number

09420012425263

Quantity per Package

20

Contains DI Package

09420012432308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK