Catalog Number

20760F-A

Brand Name

VENTILATOR CIRCUIT

Version/Model Number

20760F-A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 21, 2018

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

75faf946-6189-4b6f-a75c-9728d5ba757e

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

September 21, 2016

Package DI Number

00612649102252

Quantity per Package

30

Contains DI Package

00612649185569

Package Discontinue Date

June 21, 2018

Package Status

Not in Commercial Distribution

Package Type

-