Catalog Number

PRT-00569-001

Brand Name

VOCSN Roll Stand

Version/Model Number

Roll Stand

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

K162877

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

a839bc8e-0859-4aaa-80ea-f5a9f0f35a0e

Public Version Date

April 21, 2020

Public Version Number

1

DI Record Publish Date

April 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-