TeleRPM Blood Glucose Monitoring System

GUDID 00860004687535

Remote Patient Devices LLC

Blood glucose/blood pressure monitoring system, home-use

• Primary Device ID: 00860004687535
• NIH Device Record Key: 5bd733d9-1390-4c58-b6ce-d8351cf540ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TeleRPM Blood Glucose Monitoring System
• Version Model Number: TMB-2282-G
• Company DUNS: 121900487
• Company Name: Remote Patient Devices 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: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860004687535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223722

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: 2024-01-31
• Device Publish Date: 2024-01-23

Devices Manufactured by Remote Patient Devices LLC

• 00860004687535 - TeleRPM Blood Glucose Monitoring System: 2024-01-31
• 00860004687535 - TeleRPM Blood Glucose Monitoring System: 2024-01-31
• 00860004687542 - TeleRPM Blood Glucose Meter: 2024-01-31
• 00860004687559 - TeleRPM Blood Glucose Test Strip: 2024-01-31
• 00860004687566 - Control Solution: 2024-01-31
• 00860004687573 - Single Use Lancets: 2024-01-31
• 00860004687580 - Lancing Device: 2024-01-31
• 00860004687528 - Pro Cellular Blood Pressure Monitor: 2022-01-10