| Primary Device ID | 06430035220335 |
| NIH Device Record Key | 79f8bd3f-54c4-46a3-8ce0-db3473872b86 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fast-Fix ECG Electrode |
| Version Model Number | 901155 |
| Company DUNS | 369960000 |
| Company Name | Mega Elektroniikka Oy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com | |
| Phone | +358400541179 |
| bbs@bittium.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06430035220335 [Primary] |
| DRX | Electrode, Electrocardiograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-06 |
| Device Publish Date | 2018-07-04 |
| 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 | 2018-08-06The Fast-Fix ECG Electrode is a user-friendly, single-use electrode meant to use with Faros ECG devices. The electrode is affixed to the patient's che |
| 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 |