Catalog Number

215016

Brand Name

Vivo 50

Version/Model Number

US

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

88837b1e-9bbb-434b-97ed-5cb61c98ecfa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 07, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-