Catalog Number

N4OX-420FHTMBA

Brand Name

Western/Scott Fetzer

Version/Model Number

N4OX-420FHTMBA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

For Single-Use

-

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Public Device Record Key

0c5cdb90-8d5c-4d9e-9e4d-a347628a5432

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

April 30, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-