Catalog Number

-

Brand Name

Volara System

Version/Model Number

M08085

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

-

Product Code

NHJ

Product Code Name

DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Public Device Record Key

e55761f7-7b76-4966-b44d-8b4a4c83d748

Public Version Date

May 18, 2020

Public Version Number

2

DI Record Publish Date

March 10, 2020

Package DI Number

10887761985015

Quantity per Package

5

Contains DI Package

00887761985018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-