Bittium Faros

GUDID 06430035220366

Device for 3-channel ECG and motion measurement, monitoring and data collection

Mega Elektroniikka Oy

Telemetric electrocardiographic ambulatory recorder

• Primary Device ID: 06430035220366
• NIH Device Record Key: e973b834-363b-44dd-919d-e1c338a56897
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bittium Faros
• Version Model Number: Faros 14d
• Company DUNS: 369960000
• Company Name: Mega Elektroniikka Oy
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035220366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182030

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: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-10-23

Devices Manufactured by Mega Elektroniikka Oy

• 06430035220366 - Bittium Faros: 2019-11-08Device for 3-channel ECG and motion measurement, monitoring and data collection
• 06430035220366 - Bittium Faros: 2019-11-08 Device for 3-channel ECG and motion measurement, monitoring and data collection
• 06430035220311 - Faros 360 waterproof: 2019-11-08 Device for 3-channel ECG and motion measurement, monitoring and data collection.
• 06430035220335 - Fast-Fix ECG Electrode: 2018-08-06 The Fast-Fix ECG Electrode is a user-friendly, single-use electrode meant to use with Faros ECG devices. The electrode is affixe
• 06430035220014 - FemiScan: 2018-07-06 FemiScan device is for monitoring and recording muscle activity of the pelvic floor muscles by using EMG-signals.
• 06430035220021 - FemiScan: 2018-07-06 Electrode for FemiScan HomeTrainer (HTCS) device. For single patient use.
• 06430035220151 - Faros: 2018-07-06 Device for 1-channel ECG and motion measurement and data collection
• 06430035220168 - Faros: 2018-07-06 Device for 1-channel ECG and motion measurement, monitoring and data collection
• 06430035220175 - Faros: 2018-07-06 Device for 3-channel ECG and motion measurement, monitoring and data collection