Catalog Number

-

Brand Name

Mask ClassicStar,NIV,w/AAV,M

Version/Model Number

MP01571

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

Yes

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

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

8c4a6f63-7dd7-41ab-b43a-acbcf151d0c2

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-