Catalog Number

PRT-01092-000

Brand Name

VOCSN Nebulizer Filters

Version/Model Number

5-Pack

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

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

K162877,K162877

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

ff326e44-aa46-4ade-bd77-7924cc1cfcc9

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-