Catalog Number

HYB571

Brand Name

Hybrid NE

Version/Model Number

SM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

2ddeae12-bf91-4686-bd13-2896d9df82e9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2015

Package DI Number

M694HYB5715

Quantity per Package

3

Contains DI Package

M694HYB5713

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton