BIOFLUX

GUDID B635BIOFLUX101

BIOTRICITY INC

Electrocardiography telemetric monitoring system transmitter Electrocardiography telemetric monitoring system transmitter

• Primary Device ID: B635BIOFLUX101
• NIH Device Record Key: 4e902b39-b065-4703-92cf-59861d26300a
• 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	B635BIOFLUX100 [Primary]
HIBCC	B635BIOFLUX101 [Package]; Contains: B635BIOFLUX100; Package: [5 Units]; In Commercial Distribution
HIBCC	B635BIOFLUX102 [Package]; Package: [2 Units]; In Commercial Distribution
HIBCC	B635BIOFLUX103 [Package]; Contains: B635BIOFLUX100; Package: [2 Units]; In Commercial Distribution
HIBCC	B635BIOFLUX104 [Package]; Contains: B635BIOFLUX100; Package: [3 Units]; In Commercial Distribution
HIBCC	B635BIOFLUX105 [Package]; Contains: B635BIOFLUX100; Package: [4 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-07
• Device Publish Date: 2018-05-02

On-Brand Devices [BIOFLUX]

• B635BIOFLUX101: 1.0
• B635BIOFLUX1A0: 1.0