Catalog Number

20725F-B

Brand Name

VENTILATOR CIRCUIT

Version/Model Number

20725F-B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 10, 2019

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

BZO

Product Code Name

SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Public Device Record Key

1c161f8f-ce68-486e-9ef4-9ad591d256b6

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

September 21, 2016

Package DI Number

00612649102191

Quantity per Package

30

Contains DI Package

00612649185514

Package Discontinue Date

October 10, 2019

Package Status

Not in Commercial Distribution

Package Type

-