Bladder Scanner

GUDID 06975124100285

Peaksonic M2-W is a hand-held portable bladder volumeter, which can be used in surgery, emergency, ICU, obstetrics, gynecology, radiotherapy, sanatorium and other departments. It can provide a basis for clinical catheterization, evaluate the residual urine after urination, and assist in the diagnosis of bladder and kidney diseases. The system is also applicable to patients with lower limb disability or loss of automatic urination function to confirm the appropriate urination time.

Suzhou PeakSonic Medical Technology Co.,LTD.

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• Primary Device ID: 06975124100285
• NIH Device Record Key: 6d0753af-d733-436d-946a-d56d983bb851
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bladder Scanner
• Version Model Number: M2-W
• 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	06975124100285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190769

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: 2022-07-27
• Device Publish Date: 2022-07-19

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
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• 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