On Call Express Blood Glucose Monitoring System - Blood Glucose Monitoring System includes Meter, - ACON LABORATORIES, INC.

Duns Number:781100966

Device Description: Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1 Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)

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More Product Details

Catalog Number

-

Brand Name

On Call Express Blood Glucose Monitoring System

Version/Model Number

G115-10D

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132086,K132086,K132086,K132086

Product Code Details

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Device Record Status

Public Device Record Key

d5fe2978-9b9d-43c9-9333-564b8ba32f9c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10682607557155

Quantity per Package

4

Contains DI Package

00682607557158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"ACON LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 6