Catalog Number

-

Brand Name

Mask NovaStarTS,NIV,w/AAV,S

Version/Model Number

MP01576

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K081743,K081743

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

215d7e1c-b10b-46a9-b341-3d76492f3150

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

October 24, 2015

Package DI Number

04048675253433

Quantity per Package

3

Contains DI Package

04048675041146

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-