| Primary Device ID | 00841517100070 |
| NIH Device Record Key | 2fbcf594-b4c5-4498-8fea-af65f415d62b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | H-Universal Stand |
| Version Model Number | P12163-13 |
| 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 |
| Storage Environment Temperature | Between -35 Degrees Celsius and 65 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841517100070 [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 | 2016-09-12 |
| 00841517102173 | Diagnostic Ultrasound System Accessory |
| 00841517102135 | Diagnostic Ultrasound System Accessory |
| 00841517102067 | Diagnostic Ultrasound System Accessory |
| 00841517101756 | Diagnostic Ultrasound System Accessory |
| 00841517100070 | Diagnostic Ultrasound System Accessory |
| 00841517105761 | Diagnostic Ultrasound System Accessory |
| 00841517106430 | Diagnostic Ultrasound System Accessory |
| 00841517108120 | Diagnostic Ultrasound System Accessory |