Catalog Number

224516

Brand Name

Vivo 65

Version/Model Number

US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K160481,K160481

Product Code

NOU

Product Code Name

Continuous, Ventilator, Home Use

Public Device Record Key

dd1af633-e9b2-459f-9562-d3e6cad4c0e6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 24, 2017

Package DI Number

07321822245169

Quantity per Package

1

Contains DI Package

07321822240003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box