Catalog Number

3012590061

Brand Name

Urisys 2400 Calibration strip

Version/Model Number

3012590061

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K012397

Product Code

JIO

Product Code Name

BLOOD, OCCULT, COLORIMETRIC, IN URINE

Public Device Record Key

3da007c0-f644-4576-a7d4-ef19ab7227d4

Public Version Date

December 21, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-