EasyMax Blood Glucose Test Strip

Basic Information

• Brand Name: EasyMax Blood Glucose Test Strip
• Primary DI: 00885017000010
• Version / Model: EasyMax
• Company Name: EPS BIO TECHNOLOGY CORP.
• Labeler DUNS: 658620117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-12
• Public Version: 3
• Public Version Date: 2018-11-29
• Public Version Status: Update
• Public Device Record Key: d1e2cd11-e4c0-4626-8aae-d245f052f864

Device Description

50 strips in a 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: Yes
• 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
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
Primary	00885017000010	GS1
Package	01885017000019	GS1	carton	250	In Commercial Distribution
Package	10885017000017	GS1	carton	250	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 40 – 85 Percent (%) Relative Humidity