Catalog Number

99GM280DR1

Brand Name

ODM

Version/Model Number

Diathrive+ Blood Glucose Monitoring System

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

K170143,K170143,K170143

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

a3d8b995-54fc-41ba-b67f-857be36168f9

Public Version Date

January 27, 2020

Public Version Number

1

DI Record Publish Date

January 17, 2020

Package DI Number

20883489002383

Quantity per Package

50

Contains DI Package

00883489002389

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box