Caresono

GUDID 16971003430013

Caresono HD5 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.

Caresono Technology Co.,Ltd.

Bladder volume ultrasound imaging system

• Primary Device ID: 16971003430013
• NIH Device Record Key: bfe110fe-c81a-4f54-a0ed-18ac48d9cc08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Caresono
• Version Model Number: HD5
• Company DUNS: 546977655
• Company Name: Caresono 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16971003430013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131227

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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: 2025-02-12
• Device Publish Date: 2025-02-04

On-Brand Devices [Caresono ]

• 16971003430037: Caresono HD2 is a 3D ultrasound bladder volume instrument used to measure bladder volume and bla
• 16971003430020: Caresono HD3 is a 3D ultrasound bladder volume instrument used to measure bladder volume and bla
• 16971003430013: Caresono HD5 is a 3D ultrasound bladder volume instrument used to measure bladder volume and bla