Catalog Number

-

Brand Name

My Yodoc

Version/Model Number

SYD-M10PBBK

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

KQO

Product Code Name

Automated Urinalysis System

Public Device Record Key

a88c8fbe-ec45-4480-a65b-2cbf622e9ba0

Public Version Date

April 20, 2020

Public Version Number

1

DI Record Publish Date

April 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-