Bladder Scanner

GUDID 06975124100773

PeakSonic M5 is a 3D ultrasound bladder volume instrument used to measure bladder volume and bladder wall thickness noninvasively. It is widely used in hospitals, elderly care facilities and rehabilitation institutes.

Suzhou PeakSonic Medical Technology Co.,LTD.

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• 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 Identifiers

Device Issuing Agency	Device ID
GS1	06975124100773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213488

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: 2023-09-27
• Device Publish Date: 2023-09-19

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