TruePoint

Basic Information

• Brand Name: TruePoint
• Primary DI: 00193169642300
• Version / Model: 64230
• Catalog Number: 64230
• Company Name: OK BIOTECH CO., LTD.
• Labeler DUNS: 658796458
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2018-09-28
• Public Version: 1
• Public Version Date: 2018-10-29
• Public Version Status: New
• Public Device Record Key: a8cad95f-383f-473f-b922-52a787f7a43a

Device Description

Blood Glucose Test Strips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10193169642307	GS1	Case	24	In Commercial Distribution
Primary	00193169642300	GS1
Unit of Use	50193169642305	GS1
Package	90193169642303	GS1	Vial	1	In Commercial Distribution