On Call Plus 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 Plus Blood Glucose Monitoring System

Version/Model Number

G113-111

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Device Record Status

Public Device Record Key

361fe43e-66d6-41e0-83af-d07b045da6e2

Public Version Date

October 31, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20682607535112

Quantity per Package

20

Contains DI Package

00682607535118

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"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