Easy Talk

Basic Information

• Brand Name: Easy Talk
• Primary DI: 04719871820162
• Version / Model: 8818(BY8818G0NL4)
• Company Name: BIOTEST MEDICAL CORPORATION
• Labeler DUNS: 658447255
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-02
• Public Version: 3
• Public Version Date: 2026-04-13
• Public Version Status: Update
• Public Device Record Key: d45dc629-dd5a-44e5-818f-27b116b5fd16
• Distribution End Date: 2016-05-02

Device Description

Easy Talk Blood Glucose Test Strip(25pc/vial)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2
NBX	Stimulator, Electrical, Implanted, Functional (For Lower Limb Mobility)

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. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719871820162	GS1