BIOFLUX

GUDID B635BIOFLUX1A0

BIOTRICITY INC

Electrocardiography telemetric monitoring system transmitter

• Primary Device ID: B635BIOFLUX1A0
• NIH Device Record Key: 255002ce-9cb5-4253-963a-d848f4b0486f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOFLUX
• Version Model Number: 1.0
• Company DUNS: 023227352
• Company Name: BIOTRICITY 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B635BIOFLUX1A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172311

FDA Product Code

• DXH: Transmitters And Receivers, Electrocardiograph, Telephone

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: 2022-09-08
• Device Publish Date: 2022-08-31

On-Brand Devices [BIOFLUX]

• B635BIOFLUX101: 1.0
• B635BIOFLUX1A0: 1.0