| Primary Device ID | 08809276941480 |
| NIH Device Record Key | 23fe017b-d922-47dc-9f46-642bbb0b143f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPM-300 |
| Version Model Number | 110111-010000 |
| Company DUNS | 689708212 |
| Company Name | Bionet CO,LTD |
| Device Count | 4 |
| 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 | true |
| 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 | 08809276941480 [Primary] |
| GS1 | 08809276949040 [Unit of Use] |
| BZG | Spirometer, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-08-07 |
| Device Publish Date | 2016-09-12 |
| 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 | 2021-07-23 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 |