Easy Trak Blood Glucose Test Strips 25ct

Basic Information

• Brand Name: Easy Trak Blood Glucose Test Strips 25ct
• Primary DI: 00891237001423
• Version / Model: 200020049
• Catalog Number: 1423
• Company Name: HOME AIDE DIAGNOSTICS, INC.
• Labeler DUNS: 783518983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-05-03
• Public Version: 5
• Public Version Date: 2026-04-13
• Public Version Status: Update
• Public Device Record Key: d8255b8a-62ba-4a7c-93f3-72ff34414082

Device Description

25ct bottle Easy Trak blood glucose test strips for use with Easy Trak blood glucose monitoring system

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
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. 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	00891237001423	GS1
Unit of Use	50891237001428	GS1
Package	10891237001420	GS1	Box	2	In Commercial Distribution
Package	20891237001427	GS1	LG Case	120	In Commercial Distribution
Package	40891237001421	GS1	SM case	80	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090389	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit