| Primary Device ID | 07290016880533 |
| NIH Device Record Key | d14af57d-2e6f-4609-965d-7b36d31f8222 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Falcon/Xpress |
| Version Model Number | Falcon/Xpress |
| Company DUNS | 533070236 |
| Company Name | VIASONIX LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | 07290016880533 [Primary] |
| JOP | Transducer, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-06 |
| Device Publish Date | 2024-12-27 |
| 07290016880441 - Detachable PPG Clip sensor | 2025-01-06 The detachable PPG Clip sensor is similar in enclosure to a standard pulse oximeter. It is designed primarily to fit comfortabl |
| 07290016880533 - Falcon/Xpress | 2025-01-06The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients. |
| 07290016880533 - Falcon/Xpress | 2025-01-06 The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients. |
| 07290016880489 - Pressure Cuff Size 12L | 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure |
| 07290016880496 - Pressure Cuff Size 2.5 | 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure |
| 07290016880502 - Pressure Cuff Size 1.9 | 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure |
| 07290016880519 - Pressure Cuff Size 1.6 | 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure |
| 07290016880526 - Pressure Cuff Size 7 | 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure |
| 07290016880465 - Pressure Cuff Size 10 | 2023-07-03 The intended use of the pressure cuffs is to measure non-invasively blood pressure |