25 EasyMax 15 FTS Set EN-ES

GUDID 10885017000284

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.

EPS BIO TECHNOLOGY CORP.

Glucose IVD, control

• Primary Device ID: 10885017000284
• NIH Device Record Key: 2c745523-3328-434e-aae9-8fa3abe2cf39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 25 EasyMax 15 FTS Set EN-ES
• Version Model Number: EASY MAX 15
• Company DUNS: 658620117
• Company Name: EPS BIO TECHNOLOGY CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw
• Phone: 866-994-3345
• Email: info@epsbio.com.tw

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885017000287 [Primary]
GS1	10885017000284 [Package]; Contains: 00885017000287; Package: carton [162 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112272

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-18
• Device Publish Date: 2020-12-10

Devices Manufactured by EPS BIO TECHNOLOGY CORP.

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• 10885017000277 - 25 EasyMax FTS Set EN-ES: 2020-12-18 The EASY MAX Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples
• 10885017000284 - 25 EasyMax 15 FTS Set EN-ES: 2020-12-18The 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.
• 10885017000284 - 25 EasyMax 15 FTS Set EN-ES: 2020-12-18 The EASY MAX 15 Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samp
• 10885017000550 - EasyMax NHCS Set EN: 2020-07-01 1 bottle of Level 2 Solution
• 10885017000567 - EasyMax 15 NHCS Set EN: 2020-07-01 a bottle of level 2 control solution
• 01885017000101 - EasyMax LTC Self-Monitoring Blood Glucose System: 2020-06-23 Semi kit: one blood glucose meter
• 10885017000307 - FortisCare Self-Monitoring Blood Glucose System: 2020-02-07 1 blood glucose meter