| Primary Device ID | 00841517102234 |
| NIH Device Record Key | 1bee5f7d-1dbd-4ebd-b3f8-2d7f6ecb6528 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HFL38xi/13-6 MHz, armored |
| Version Model Number | P20377-10 |
| Catalog Number | P20377 |
| 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(999)999-9999 |
| xyz@xyz.com |
| Storage Environment Temperature | Between -35 Degrees Celsius and 65 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841517102234 [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 | 5 |
| Public Version Date | 2020-02-28 |
| Device Publish Date | 2017-06-22 |
| 00841517109400 - T8-3 | 2024-02-14 Diagnostic ultrasound transducer |
| 00841517109011 - TEExi/8-3 MHz | 2024-02-07 Diagnostic Ultrasound Transducer |
| 00841517109103 - C35x/8-3 Mhz | 2024-02-07 DIAGNOSTIC ULTRAOSUND TRANSDUCER |
| 00841517109424 - C35xp/8-3 MHz | 2024-02-07 Diagnostic Ultrasound Transducer |
| 00841517100018 - P11-3 | 2024-02-01 Diagnostic ultrasound system- transducer |
| 00841517110192 - L13-6 | 2024-02-01 DIAGNOSTIC ULTRASOUND SYTSEM- TRANSDUCER |
| 00841517110178 - Sonosite PX | 2024-01-22 SONOSITE PX ULTRASOUND SYSTEM, 3.1.1, UKCA |
| 00841517110185 - SonoSite LX | 2024-01-22 Diagnostic ultrasound system |