Catalog Number

-

Brand Name

Newport

Version/Model Number

SEN3420A

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K111146

Product Code

CBK

Product Code Name

Ventilator, continuous, facility use

Public Device Record Key

861239c0-c1ac-440a-973e-32e6123d1e5d

Public Version Date

October 18, 2021

Public Version Number

1

DI Record Publish Date

October 10, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-