Catalog Number

DE2100X13B

Brand Name

Trilogy Evo

Version/Model Number

Trilogy Evo Ventilator with oxygen blending model, Germany

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

-

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

17be2783-09f1-4c79-b224-43b580c89f4e

Public Version Date

March 04, 2021

Public Version Number

2

DI Record Publish Date

April 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-