BladderScan® 0620-0225

GUDID 00879123002518

VERATHON INC

Ultrasound system quality assurance device

• Primary Device ID: 00879123002518
• NIH Device Record Key: 813d30a7-2846-4432-b285-ed7df1aa94a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BladderScan®
• Version Model Number: BVI 6000 Series
• Catalog Number: 0620-0225
• 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: false
• 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	00879123002518 [Primary]
GS1	10879123002515 [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 [BladderScan®]

• 10879123006179: Pediatric Phantom
• 00879123006141: BVI 6000 Series
• 00879123005755: Prime
• 10879123005660: BVI 3000
• 00879123005571: BVI 6000 Series
• 00879123005564: BVI 6000 Series
• 00879123005533: BVI 3000
• 00879123005526: BVI 9400
• 10879123005493: Prime
• 10879123005165: Prime
• 10879123004595: Prime
• 10879123004502: Prime
• 00879123004499: Prime
• 10879123002973: BVI 9400
• 10879123002966: BVI 9400
• 10879123002638: BVI 9400
• 10879123002591: BVI 3000
• 10879123002577: BVI 3000
• 10879123002522: Training Phantom
• 00879123002518: BVI 6000 Series
• 10879123002508: BVI 3000
• 00879123002297: BVI 3000
• 10879123002256: BVI 9400
• 10879123002232: BVI 3000
• 10879123001969: Tissue-Equivalent Phantom
• 10879123001945: BVI 9400
• 00879123001634: BVI 6000 Series
• 10879123006490: BladderScan® Prime Plus™ Probe
• 00879123006486: BladderScan® Prime Plus™ Console
• 10879123008234: i10™
• 10879123008142: i10™
• 00879123007896: i10™
• 00879123007452: i10™
• 00879123007445: i10™
• 00879123007438: i10™
• 10879123007411: i10™
• 00879123001511: i10™
• 10879123008012: BladderScan® Prime Plus™ Probe, Probe Exchange
• 10879123004755: BVI 3000
• 10879123003659: BVI 9400
• 10879123003642: BVI 3000
• 10879123001754: BVI 9400
• 10879123001594: BVI 3000