| Primary Device ID | 06945121407083 |
| NIH Device Record Key | b74988f4-288a-473d-a2fd-d986c1bf99db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | i8 Diagnostic Ultrasound System |
| Version Model Number | i8 |
| 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 | 06945121406567 [Primary] |
| GS1 | 06945121406871 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121406888 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121406895 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121406901 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121406918 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121406925 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121406932 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121406949 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121406956 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121406963 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121406970 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121406987 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121406994 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121407007 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121407014 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121407021 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121407038 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121407045 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121407052 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121407069 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121407076 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| GS1 | 06945121407083 [Package] Contains: 06945121406567 Package: [1 Units] In Commercial Distribution |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-08 |