ODM

Basic Information

• Brand Name: ODM
• Primary DI: 00883489002419
• Version / Model: Diathrive+ Blood Glucose Test Strip
• Catalog Number: 99GS280D51
• Company Name: BIONIME CORPORATION
• Labeler DUNS: 658637244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2020-01-17
• Public Version: 1
• Public Version Date: 2020-01-27
• Public Version Status: New
• Public Device Record Key: 91b9ca22-783a-4627-8302-57d86d5685ad

Device Description

25 strips - 80883489002415

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20883489002420	GS1	Box	12	In Commercial Distribution
Package	10883489002423	GS1	Box	20	In Commercial Distribution
Package	00883489002426	GS1	Box	2	In Commercial Distribution
Primary	00883489002419	GS1
Unit of Use	80883489002415	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K170143	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 39 – 86 Degrees Fahrenheit