Catalog Number

20760F-B

Brand Name

VENTILATOR CIRCUIT

Version/Model Number

20760F-B

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

-

Product Code

BZO

Product Code Name

SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Public Device Record Key

bc03029b-3bcc-4488-acb6-3247475544a2

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

00612649102269

Quantity per Package

30

Contains DI Package

00612649185576

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-