| Primary Device ID | 06945121412681 |
| NIH Device Record Key | faae6f48-87bd-46f2-8bbc-56454844a825 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SonoBook Series Diagnostic Ultrasound Systems |
| Version Model Number | SonoBook 8 |
| Company DUNS | 544914187 |
| Company Name | CHISON Medical Technologies Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06945121412681 [Primary] |
| GS1 | 06945121412698 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121412704 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121412711 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121412728 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121412735 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121412742 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121412759 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121412766 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121412773 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121412780 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121412797 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121412803 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121412810 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121412827 [Package] Package: [1 Units] In Commercial Distribution |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-06 |
| Device Publish Date | 2018-11-05 |
| 06945121412681 | SonoBook 8 |
| 06945121411172 | SonoBook 9 |
| 06945121413305 | SonoBook 7 |
| 06945121414166 | SonoBook 5 |