Catalog Number

-

Brand Name

Model EMV+ Vent, Army, COMMERCIAL

Version/Model Number

499-0005-01-23

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K111473

Product Code

CBK

Product Code Name

Ventilator, continuous, facility use

Public Device Record Key

e69d7ba7-696e-4975-9866-188c6573cb0e

Public Version Date

August 31, 2020

Public Version Number

1

DI Record Publish Date

August 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-