Catalog Number

OJR410B

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

OJR410B

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

K173770,K173770

Product Code

CBP

Product Code Name

Valve, Non-Rebreathing

Public Device Record Key

f8b16dda-eaaa-4d2e-8ed6-4d3ea0f2c7f3

Public Version Date

August 10, 2022

Public Version Number

1

DI Record Publish Date

August 02, 2022

Package DI Number

09420012448842

Quantity per Package

5

Contains DI Package

09420012448835

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK