Bladder Scanner

GUDID 06975124100537

The instrument is suitable for the measurement of bladder volume in hospitals, nursing homes and homes. To provide the basis for the implementation of clinical catheterization, evaluate the residual volume after micturition, and make auxiliary diagnosis for the diseases of bladder and renal function. The instrument is also suitable for people with lower body disability and loss of self urination function to master the timing of urination.

Suzhou PeakSonic Medical Technology Co.,LTD.

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• Primary Device ID: 06975124100537
• NIH Device Record Key: 90032db7-f502-4eb5-90b9-a17e25dad7e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bladder Scanner
• Version Model Number: M4
• 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	06975124100537 [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: 2022-04-21
• Device Publish Date: 2022-04-13

On-Brand Devices [Bladder Scanner]

• 06975124100537: The instrument is suitable for the measurement of bladder volume in hospitals, nursing homes and
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