Bladder Scanner

GUDID 06972608310079

The M Series Bladder Scanner provides non-invasive volume bladder measurement utilizing real-time ultrasound imaging and measurement.

Suzhou Lischka Medtech Co.,Ltd

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• Primary Device ID: 06972608310079
• NIH Device Record Key: 48846e77-fbe3-418b-96d0-060136bb4049
• Commercial Distribution Discontinuation: 2021-08-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bladder Scanner
• Version Model Number: M4
• Company DUNS: 560053481
• Company Name: Suzhou Lischka Medtech 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	06972608310079 [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: 2021-05-26
• Device Publish Date: 2021-05-18

On-Brand Devices [Bladder Scanner]

• 06972608310017: The M Series Bladder Scanner provides non-invasive volume bladder measurement utilizing real-tim
• 06972608310055: The M Series Bladder Scanner provides non-invasive volume bladder measurement utilizing real-tim
• 06972608310086: The M Series Bladder Scanner provides non-invasive volume bladder measurement utilizing real-tim
• 06972608310079: The M Series Bladder Scanner provides non-invasive volume bladder measurement utilizing real-tim
• 06972608310062: The M Series Bladder Scanner provides non-invasive volume bladder measurement utilizing real-tim