EdgeFlow UH10

GUDID 08809887550002

Bladder volume ultrasound imaging system

EdgeCare Inc.

Bladder volume ultrasound imaging system

• Primary Device ID: 08809887550002
• NIH Device Record Key: 841a7019-02a1-4c22-9149-7c3ca102c32a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeFlow UH10
• Version Model Number: UH10101
• Company DUNS: 695523164
• Company Name: EdgeCare Inc.
• 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: false
• 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	08809887550002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231677

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: 2024-10-16
• Device Publish Date: 2024-10-08