Catalog Number

-

Brand Name

EVOLUTION

Version/Model Number

T

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113743

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

2b0ab34a-7ae5-407f-995f-6d2e89131063

Public Version Date

August 28, 2020

Public Version Number

1

DI Record Publish Date

August 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-