TeleMate Health &TeleRPM

GUDID 00850042929421

Lancing Device

Mio Labs Inc.

Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable

• Primary Device ID: 00850042929421
• NIH Device Record Key: 19d1ddc1-3ca6-4531-a25e-05f58a9a3171
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TeleMate Health &TeleRPM
• Version Model Number: HH-XIII-T
• 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: 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	00850042929421 [Primary]

FDA Product Code

• QRL: Multiple Use Blood Lancet For Single Patient Use Only

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