Catalog Number

5465349

Brand Name

LEADER

Version/Model Number

5465349

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

474961e6-838d-4af0-b344-9d565ccbbb6e

Public Version Date

July 02, 2021

Public Version Number

2

DI Record Publish Date

April 18, 2019

Package DI Number

50096295135850

Quantity per Package

24

Contains DI Package

00096295135855

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE