Catalog Number

ZCD100

Brand Name

Zoey CPAP Cleaner

Version/Model Number

ZCD100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MEC

Product Code Name

Disinfector, Medical Devices

Public Device Record Key

3bf24a8d-c201-4111-bd22-54a7da03b08d

Public Version Date

March 09, 2020

Public Version Number

1

DI Record Publish Date

February 28, 2020

Package DI Number

10848530090897

Quantity per Package

4

Contains DI Package

00848530090890

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer packaging