| Primary Device ID | 00841517100377 |
| NIH Device Record Key | 6e6289cd-3ef6-4f2c-9d3a-28d85a3a6c6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HFL38xi/13-6 MHz |
| Version Model Number | P20311-10A |
| 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 | 00841517100377 [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 |
| 00841517104825 | Diagnostic Ultrasound Transducer |
| 00841517104818 | Diagnostic Ultrasound Transducer |
| 00841517100377 | Diagnostic Ultrasound Transducer |
| 00841517100360 | Diagnostic Ultrasound Transducer |
| 00841517105624 | P20311-20A |
| 00841517106133 | Diagnostic Ultrasound Transducer |
| 00841517107178 | Diagnostic Ultrasound Transducer |
| 00841517109035 | Diagnostic Ultrasound Transducer |
| 00841517109028 | Diagnostic Ultrasound Transducer |
| 00841517110475 | Diagnostic Ultrasound Transducer |
| 00841517110444 | Diagnostic Ultrasound Transducer |