Catalog Number

-

Brand Name

TopCare

Version/Model Number

UTES

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K063295,K063295

Product Code

JMT

Product Code Name

Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)

Public Device Record Key

4bdb2de5-a863-4688-9002-c0c4dcb77a2f

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

August 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-