Eocene

GUDID 00854067005191

Smart Diabetes Bluetooth Glucose Monitor

VALUE PROVIDERS LLC

Blood glucose/blood pressure monitoring system, home-use

• Primary Device ID: 00854067005191
• NIH Device Record Key: 05f5d4fd-6a7f-451f-97d9-f37cdfdcc7fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eocene
• Version Model Number: EHS-SDMK-BT
• Company DUNS: 079213227
• Company Name: VALUE PROVIDERS LLC
• 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: true
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (321) 567-0688
• Email: troy@valueprovidersinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854067005191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111456

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-02

On-Brand Devices [Eocene]

• 00854067005276: Smart Diabetes Thermometer
• 00854067005269: Smart Diabetes Wireless Weight Scale
• 00854067005252: Smart Diabetes Blood Pressure Monitor
• 00854067005221: Smart Diabetes Control Solution
• 00854067005207: Smart Diabetes Glucose Test Strips
• 00854067005191: Smart Diabetes Bluetooth Glucose Monitor