FibroScan

GUDID 03662264001147

ECHOSENS

Hepatic ultrasound elastography system

• Primary Device ID: 03662264001147
• NIH Device Record Key: a9b5e3c0-c9bd-41d4-9ae0-1914b5788b32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FibroScan
• Version Model Number: FibroScan 430 MINI+
• Company DUNS: 571069108
• Company Name: ECHOSENS
• 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

Customer Support Contacts

• Phone: +33149818929
• Email: service@echosens.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662264001147 [Previous]
GS1	03662264001208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172142

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: 4
• Public Version Date: 2020-03-11
• Device Publish Date: 2017-11-06

On-Brand Devices [FibroScan]

• 03662264001147: FibroScan 430 MINI+
• 03662264001062: FibroScan 530 Compact
• 03662264001048: FibroScan 502 Touch
• 03662264001031: FibroScan 502 Touch
• 03662264000072: XL+
• 03662264000065: Pediatric probe
• 03662264000058: Adult probe
• 03662264001161: FibroScan 630
• 03662264001222: FibroScan 230