ScanPoint® 0570-0168

GUDID 00879123001641

VERATHON INC

Bladder volume ultrasound imaging system

• Primary Device ID: 00879123001641
• NIH Device Record Key: 523b9022-ab7f-44bb-8040-54115f6b9582
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScanPoint®
• Version Model Number: Docking Station
• Catalog Number: 0570-0168
• Company DUNS: 130598584
• Company Name: VERATHON 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00879123001641 [Primary]
GS1	10879123001648 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022153

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [ScanPoint®]

• 00879123006134: QuickPrint
• 00879123006127: ScanPoint®
• 00879123004239: ScanPoint Local Client
• 00879123001641: Docking Station