| Primary Device ID | 00841517100582 |
| NIH Device Record Key | 1b7c0f9d-15ca-4614-83f3-e800550bc608 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | rP19x/5-1 MHz |
| Version Model Number | P21015-10 |
| Company DUNS | 014438860 |
| Company Name | FUJIFILM SONOSITE, INC. |
| 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 |
| Phone | 1-877-657-8118 |
| ffss-service@fujifilm.com |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841517100582 [Primary] |
| ITX | Transducer, ultrasonic, 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 | 2018-07-06 |
| Device Publish Date | 2016-09-13 |
| 00841517104948 | Diagnostic Ultrasound Transducer |
| 00841517100599 | Diagnostic Ultrasound Transducer |
| 00841517100582 | Diagnostic Ultrasound Transducer |
| 00841517106140 | Diagnostic Ultrasound Transducer |
| 00841517107154 | Diagnostic Ultrasound Transducer |
| 00841517109066 | Diagnostic Ultrasound Transducer |
| 00841517110574 | Diagnostic Ultrasound Transducer |