TeleMate Health &TeleRPM

GUDID 00850042929414

Single Use Lancets

Mio Labs Inc.

Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use

• Primary Device ID: 00850042929414
• NIH Device Record Key: 3aafe2eb-e376-42ca-abfe-417e3d67d399
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TeleMate Health &TeleRPM
• Version Model Number: I
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042929414 [Primary]

FDA Product Code

• QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

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