Catalog Number

99GS280D51

Brand Name

ODM

Version/Model Number

Diathrive+ Blood Glucose Test Strip

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)

-

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,K170143,K170143

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

91b9ca22-783a-4627-8302-57d86d5685ad

Public Version Date

January 27, 2020

Public Version Number

1

DI Record Publish Date

January 17, 2020

Package DI Number

20883489002420

Quantity per Package

12

Contains DI Package

10883489002423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box