Catalog Number

-

Brand Name

TRUEplus

Version/Model Number

TRUEplus Ketone Test Strips

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

-

Product Code

JIN

Product Code Name

Nitroprusside, Ketones (Urinary, Non-Quant.)

Public Device Record Key

bd0c7872-3ba1-42d1-a4b3-7677aeebdb9e

Public Version Date

October 29, 2020

Public Version Number

1

DI Record Publish Date

October 21, 2020

Package DI Number

00311917173900

Quantity per Package

2

Contains DI Package

00021292008178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX