Catalog Number

004901

Brand Name

Vivo 50, Vivo 65, Vivo 45 LS

Version/Model Number

004901

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

K123144,K160481,K193586

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

309b7e55-15cf-4111-bba8-17894c31051b

Public Version Date

June 27, 2022

Public Version Number

1

DI Record Publish Date

June 18, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-