Health Wealth Safe TMB-2282-G

GUDID 00850042929377

TeleRPM Blood Glucose Monitoring System

Mio Labs Inc.

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 Blood glucose/blood pressure monitoring system, home-use

• Primary Device ID: 00850042929377
• NIH Device Record Key: 78bccc65-330c-4a94-a390-e535cc5d7279
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health Wealth Safe
• Version Model Number: TMB-2282-G
• Catalog Number: TMB-2282-G
• Company DUNS: 117119317
• Company Name: Mio Labs Inc.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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	00850042929377 [Primary]

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: 2024-02-06
• Device Publish Date: 2024-01-29

On-Brand Devices [Health Wealth Safe]

• 00850042929377: TeleRPM Blood Glucose Monitoring System
• 00850042929360: Lancing Device
• 00850042929353: Single Use Lancets
• 00850042929346: Control Solution
• 00850042929339: Blood Glucose Test Strip
• 00850042929322: TeleRPM Blood Glucose Meter