BladderScan® 0400-0126

GUDID 10879123005165

VERATHON INC

Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack

• Primary Device ID: 10879123005165
• NIH Device Record Key: 69a1df2c-a187-453e-852d-e5ecde69d967
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BladderScan®
• Version Model Number: Prime
• Catalog Number: 0400-0126
• 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	00879123005168 [Primary]
GS1	10879123005165 [Package]; Contains: 00879123005168; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153101

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