Catalog Number

5.433-02

Brand Name

FISSO

Version/Model Number

5.433-02-VE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 10, 2022

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

-

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

BZO

Product Code Name

Set, Tubing And Support, Ventilator (W Harness)

Public Device Record Key

89ac56f7-c97c-454b-bf38-1be394115bc5

Public Version Date

May 10, 2022

Public Version Number

3

DI Record Publish Date

October 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-