Bittium Faros 180 waterproof

GUDID 06430035220328

Device for 1-channel ECG and motion measurement, monitoring and data collection

Bittium Biosignals Oy

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• Primary Device ID: 06430035220328
• NIH Device Record Key: 28e9aace-4413-4c38-8017-10103fb45d58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bittium Faros 180 waterproof
• Version Model Number: Faros 180
• Company DUNS: 369960000
• Company Name: Bittium Biosignals 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	06430035220328 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-27
• Device Publish Date: 2021-12-17

Devices Manufactured by Bittium Biosignals Oy

• 06430035220328 - Bittium Faros 180 waterproof: 2021-12-27Device for 1-channel ECG and motion measurement, monitoring and data collection
• 06430035220328 - Bittium Faros 180 waterproof: 2021-12-27 Device for 1-channel ECG and motion measurement, monitoring and data collection
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• 06430035220588 - Bittium OmegaSnap: 2021-12-27 Bittium OmegaSnap 1-CH Adapter
• 06430035220670 - Bittium OmegaSnap: 2021-12-27 2-CH ECG Electrode
• 06430035220687 - Bittium OmegaSnap: 2021-12-27 3-CH ECG Electrode
• 06430035220694 - Bittium OmegaSnap: 2021-12-27 Bittium MiniSnap Sensitive 1-CH ECG Electrode
• 06430035220700 - Bittium OmegaSnap: 2021-12-27 Bittium OmegaSnap Multi-CH Adapter