Catalog Number

PRT-01185-000

Brand Name

VOCSN

Version/Model Number

V+Pro, English

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"

Yes

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

K162877,K162877

Product Code

BZE

Product Code Name

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Public Device Record Key

efeb7f33-a684-42d2-80b0-fab3d568662d

Public Version Date

April 21, 2020

Public Version Number

1

DI Record Publish Date

April 13, 2020

Package DI Number

00855573007914

Quantity per Package

1

Contains DI Package

00855573007877

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-