Catalog Number

-

Brand Name

HealthyMe UTI Urinary Tract Infection Test Strips

Version/Model Number

765100

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

Yes

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

K063295,K063295,K063295

Product Code

JMT

Product Code Name

DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)

Public Device Record Key

7a576b5b-d180-4e00-ac9b-8ad5aace663c

Public Version Date

May 08, 2020

Public Version Number

1

DI Record Publish Date

April 30, 2020

Package DI Number

20682607651003

Quantity per Package

24

Contains DI Package

00682607651009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton