| Primary Device ID | 16978669290005 |
| NIH Device Record Key | 904887d2-1ca9-4f3b-8da2-83fe7cf626e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Astrasono A3Pro Bladder Scanner |
| Version Model Number | A3Pro |
| Company DUNS | 449989331 |
| Company Name | Astrasono technology co.,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 | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 16978669290005 [Primary] |
| IYO | System, Imaging, Pulsed Echo, 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 | 2025-11-28 |
| Device Publish Date | 2025-11-20 |
| 16978669290012 - Astrasono A5Pro Bladder Scanner | 2026-01-23 The Astrasono A5Pro Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a handheld battery-operated devic |
| 16978669290005 - Astrasono A3Pro Bladder Scanner | 2025-11-28The Astrasono A3Pro Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a handheld battery-operated device. The device projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. It is intended to be used only by qualified medical professionals. |
| 16978669290005 - Astrasono A3Pro Bladder Scanner | 2025-11-28 The Astrasono A3Pro Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a handheld battery-operated devic |