Catalog Number

-

Brand Name

KetoSens

Version/Model Number

276156

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

K170463,K170463,K170463,K170463

Product Code

JIN

Product Code Name

Nitroprusside, Ketones (Urinary, Non-Quant.)

Public Device Record Key

5856a568-f159-42ad-a4e0-e46e702ce719

Public Version Date

November 18, 2020

Public Version Number

1

DI Record Publish Date

November 10, 2020

Package DI Number

10885325001287

Quantity per Package

25

Contains DI Package

00885325001280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack,Middle Box