Bladder Scanner

GUDID 06975124100421

PeakSonic M3 is a handheld portable bladder volume instrument, which can be applied in the department of Surgery, Emergency, ICU, Obstetric, Gynecology, radiotherapy and nursing home. It can provide the basis for clinical catheterization, evaluate the post-void residual after patient urination, and make auxiliary diagnosis on the bladder and kidney diseases. The system is also suitable for patients of lower body disability or loss of auto-urination function, to confirm the proper timing of urination.

Suzhou PeakSonic Medical Technology Co.,LTD.

Bladder volume ultrasound imaging system

• Primary Device ID: 06975124100421
• NIH Device Record Key: f3095cda-f0a3-4326-b431-3a3500dc59e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bladder Scanner
• Version Model Number: M3
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	06975124100421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201316

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-10
• Device Publish Date: 2023-04-01

On-Brand Devices [Bladder Scanner]

• 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