25 EasyMax 15 FTS Set EN-ES

Basic Information

• Brand Name: 25 EasyMax 15 FTS Set EN-ES
• Primary DI: 00885017000287
• Version / Model: EASY MAX 15
• Company Name: EPS BIO TECHNOLOGY CORP.
• Labeler DUNS: 658620117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-10
• Public Version: 2
• Public Version Date: 2021-03-15
• Public Version Status: Update
• Public Device Record Key: 2c745523-3328-434e-aae9-8fa3abe2cf39

Device Description

The EASY MAX 15 Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. The test Strips must be used with the EASY MAX 15 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, is not for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions.

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: Yes
• 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
53302	Glucose IVD, kit, enzyme spectrophotometry, rapid	A collection of reagents, and sometimes other associated materials, intended to be used for the quantitative measurement of glucose in a clinical specimen within a short period relative to standard laboratory testing procedures, using an enzyme spectrophotometry method. It is available in a variety of forms (e.g., strips, cartridges, micro-cassettes) and may be used in the laboratory, at the point-of-care, and/or in the home.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10885017000284	GS1	carton	162	In Commercial Distribution
Primary	00885017000287	GS1

Customer Contacts

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

Storage Conditions

• 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
• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius