Catalog Number

005094

Brand Name

Vivo 50

Version/Model Number

005094

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

Product Code

NOU

Product Code Name

Continuous, Ventilator, Home Use

Public Device Record Key

792c82e0-8fee-4264-84af-733e29f6a83c

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

-