Smart Diabetes

GUDID 00854067005238

Smart Diabetes Voice Glucose Monitor

VALUE PROVIDERS LLC

Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use Blood glucose/blood pressure monitoring system, home-use

• Primary Device ID: 00854067005238
• NIH Device Record Key: 28c7e4a3-c8c9-450f-99f1-52c152556782
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Diabetes
• Version Model Number: EHS-SDMK-V
• 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: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com
• Phone: 3865068139
• Email: vtrani@valueprovidersinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854067005238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133260

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: 2022-01-27
• Device Publish Date: 2022-01-19

Devices Manufactured by VALUE PROVIDERS LLC

• 00854067005238 - Smart Diabetes: 2022-01-27Smart Diabetes Voice Glucose Monitor
• 00854067005238 - Smart Diabetes: 2022-01-27 Smart Diabetes Voice Glucose Monitor
• 00854067005191 - Eocene: 2018-07-06 Smart Diabetes Bluetooth Glucose Monitor
• 00854067005252 - Eocene: 2018-07-06 Smart Diabetes Blood Pressure Monitor
• 00854067005269 - Eocene: 2018-07-06 Smart Diabetes Wireless Weight Scale
• 00854067005276 - Eocene: 2018-07-06 Smart Diabetes Thermometer
• 00854067005207 - Eocene: 2018-05-03 Smart Diabetes Glucose Test Strips
• 00854067005221 - Eocene: 2018-05-03 Smart Diabetes Control Solution