Catalog Number

EVL100500-T, EVL100500-T-NF

Brand Name

eVolution 3e Ventilator

Version/Model Number

eVolution 3e Ventilator- Turbine Essential

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

-

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

K113743

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

ae012c69-20ca-4502-8a52-67b0bdb68444

Public Version Date

August 18, 2022

Public Version Number

1

DI Record Publish Date

August 10, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-