| Primary Device ID | 18809276943597 |
| NIH Device Record Key | 6cd0c66b-4da2-4a9f-aa6c-0a2bc2be9f7b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FC700 |
| Version Model Number | FC700 |
| Company DUNS | 689708212 |
| Company Name | Bionet CO,LTD |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809276943590 [Primary] |
| GS1 | 18809276943597 [Package] Contains: 08809276943590 Package: Box [4 Units] In Commercial Distribution |
| HGM | System, Monitoring, Perinatal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-23 |
| Device Publish Date | 2021-07-15 |
| 18809276940282 - CardioXP | 2021-07-23 ELECTROCARDIOGRAPH |
| 18809276943535 - CardioCare2000 | 2021-07-23 System, ecg analysis |
| 18809276943542 - CardioTouch3000 | 2021-07-23 System, ecg analysis |
| 18809276943559 - Cardio7 | 2021-07-23 ELECTROCARDIOGRAPH |
| 18809276943597 - FC700 | 2021-07-23SYSTEM, MONITORING, PERINATAL |
| 18809276943597 - FC700 | 2021-07-23 SYSTEM, MONITORING, PERINATAL |
| 18809276943603 - FC1400 | 2021-07-23 SYSTEM, MONITORING, PERINATAL |
| 18809276943641 - BM3/BM3 Plus | 2021-07-23 MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) |
| 18809276943726 - Spiro Handle | 2021-07-23 SPIROMETER, DIAGNOSTIC |