FortisCare Blood Glucose Test Strip

GUDID 10885017000314

50 strips in a vial

EPS BIO TECHNOLOGY CORP.

Glucose IVD, kit, enzyme spectrophotometry, rapid

• Primary Device ID: 10885017000314
• NIH Device Record Key: 5e3b46a1-b78e-4d69-b3a3-d6476b319888
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FortisCare Blood Glucose Test Strip
• Version Model Number: EasyMax T1 Pro
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885017000317 [Primary]
GS1	10885017000314 [Package]; Contains: 00885017000317; Package: carton [150 Units]; In Commercial Distribution

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: 2020-02-07
• Device Publish Date: 2020-01-30

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: 2020-12-18 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