Biotricity

GUDID B635BIOTRES100

BIOTRICITY INC

Electrocardiography telemetric monitoring system transmitter

• Primary Device ID: B635BIOTRES100
• NIH Device Record Key: 36d18807-9223-4b89-be15-8f1c7aa07d60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotricity
• 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: MR Unsafe
• 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	B635BIOTRES100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211709

FDA Product Code

• MWJ: Electrocardiograph, Ambulatory (Without Analysis)

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: 2022-02-25
• Device Publish Date: 2022-02-17

Devices Manufactured by BIOTRICITY INC

• B635BIOKIT0100 - Biokit O2: 2025-10-02
• B635BIOTRESPR0 - Biotres Pro: 2024-03-15
• B635BIOFLUX1A0 - BIOFLUX: 2022-09-08
• B635BIOTRES100 - Biotricity: 2022-02-25
• B635BIOTRES100 - Biotricity: 2022-02-25
• B635BIOFLUX101 - BIOFLUX: 2019-05-07