Catalog Number

OJR414

Brand Name

Fisher and Paykel Healthcare

Version/Model Number

OJR414

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

CAT

Product Code Name

Cannula, Nasal, Oxygen

Public Device Record Key

43cf6acd-033e-4d53-ba7b-34180b4e301e

Public Version Date

August 10, 2022

Public Version Number

1

DI Record Publish Date

August 02, 2022

Package DI Number

09420012435941

Quantity per Package

20

Contains DI Package

09420012435934

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK