| Primary Device ID | 06975124100773 |
| NIH Device Record Key | 8971ff5b-86a6-4bbd-bb60-c451c1ab0676 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bladder Scanner |
| Version Model Number | M5 |
| Company DUNS | 554531949 |
| Company Name | Suzhou PeakSonic Medical Technology Co.,LTD. |
| 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 | 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 | 06975124100773 [Primary] |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-27 |
| Device Publish Date | 2023-09-19 |
| 06975124100537 | The instrument is suitable for the measurement of bladder volume in hospitals, nursing homes and |
| 06975124100285 | Peaksonic M2-W is a hand-held portable bladder volumeter, which can be used in surgery, emergenc |
| 06975124100421 | PeakSonic M3 is a handheld portable bladder volume instrument, which can be applied in the depar |
| 06975124100193 | PeakSonic M2 is a handheld portable bladder volume instrument, which can be applied in the depar |
| 06975124100773 | PeakSonic M5 is a 3D ultrasound bladder volume instrument used to measure bladder volume and bla |