Biotres Pro

GUDID B635BIOTRESPR0

BIOTRICITY INC

Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder

• Primary Device ID: B635BIOTRESPR0
• NIH Device Record Key: 00d78f05-5a14-4691-8fe5-974aa7d75b31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotres Pro
• 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	B635BIOTRESPR0 [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: 2024-03-15
• Device Publish Date: 2024-03-07

Devices Manufactured by BIOTRICITY INC

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