MIO TeleBGM Control Solution

GUDID 00850042929025

Mio Control Solution

Mio Labs Inc.

Glucose analyser IVD, home-use

• Primary Device ID: 00850042929025
• NIH Device Record Key: eca6eda7-31ab-4225-b08e-600b09de7a10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIO
• Version Model Number: VGC01
• Catalog Number: TeleBGM Control Solution
• 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: 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042929025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173140

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: 2022-09-28
• Device Publish Date: 2022-09-20

On-Brand Devices [MIO]

• 00850042929070: GBS-2104-G
• 00850042929049: Mio Lancing Device
• 00850042929032: Mio Single Use Lancets
• 00850042929025: Mio Control Solution
• 00850042929018: Blood Glucose Test Strip
• 00850042929001: Blood Glucose Meter
• 00850042929148: Mio Blood Glucose Test Strip
• 00850042929131: Mio Blood Glucose Meter
• 10850042929169: Mio Single Use Lancets
• 00850042929179: Mio Lancing Device
• 00850042929162: Mio Single Use Lancets
• 00850042929155: Mio Control Solution
• 00850042929186: MIO Blood Glucose Monitoring System