TeleRPM / Chronica

GUDID 00850042929209

TeleRPM Blood Glucose Test Strip

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 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: 00850042929209
• NIH Device Record Key: 8a18505b-8219-4b9a-8ca4-eb0dfa53cae9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TeleRPM / Chronica
• Version Model Number: TTS01
• 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: false
• Device Combination Product: false
• Single Use: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042929209 [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: 2023-09-14
• Device Publish Date: 2023-09-06

On-Brand Devices [TeleRPM / Chronica]

• 00850042929230: Lancing Device
• 00850042929223: Single Use Lancets
• 00850042929216: TeleRPM Control Solution
• 00850042929247: TeleRPM Blood Glucose Monitoring System
• 00850042929209: TeleRPM Blood Glucose Test Strip
• 00850042929193: TeleRPM Blood Glucose Meter