StatSensor - StatSensor Creatinine Meter with Battery and - NOVA BIOMEDICAL CORPORATION

Duns Number:070617139

Device Description: StatSensor Creatinine Meter with Battery and Quick Reference Guide

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More Product Details

Catalog Number

44052

Brand Name

StatSensor

Version/Model Number

1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K070068,K070068

Product Code Details

Product Code

CGL

Product Code Name

ELECTRODE, ION BASED, ENZYMATIC, CREATININE

Device Record Status

Public Device Record Key

48c6926e-4ba3-458a-be73-5c7202864577

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

10385480440520

Quantity per Package

1

Contains DI Package

00385480440523

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"NOVA BIOMEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 165
2 A medical device with a moderate to high risk that requires special controls. 210