TeleMate Health &TeleRPM

GUDID 00850042929407

Control Solution

Mio Labs Inc.

Glucose IVD, kit, electrometry

• Primary Device ID: 00850042929407
• NIH Device Record Key: e9ab6957-fea4-4687-8a93-f430606a53d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TeleMate Health &TeleRPM
• Version Model Number: TCS01
• Company DUNS: 117119317
• Company Name: Mio Labs Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	00850042929407 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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 [TeleMate Health &TeleRPM]

• 00850042929438: TeleRPM Blood Glucose Monitoring System
• 00850042929421: Lancing Device
• 00850042929414: Single Use Lancets
• 00850042929407: Control Solution
• 00850042929391: Blood Glucose Test Strip
• 00850042929384: TeleRPM Blood Glucose Meter