Helcerion 300L

GUDID 00860000879828

Transducer, Ultrasonic, Diagnostic

Healcerion Co., Ltd.

Noninvasive vascular ultrasound system probe

• Primary Device ID: 00860000879828
• NIH Device Record Key: d096868c-0124-4123-81cc-0ad773d876de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Helcerion
• Version Model Number: 300L
• Catalog Number: 300L
• Company DUNS: 688732988
• Company Name: Healcerion Co., Ltd.
• 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: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com
• Phone: 877-572-6530
• Email: tony@healcerionusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000879828 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-21
• Device Publish Date: 2019-01-21

Devices Manufactured by Healcerion Co., Ltd.

• 08809489920005 - SONON ULTRASOUND IMAGING SYSTEM: 2019-10-30
• 08809489920012 - SONON ULTRASOUND IMAGING SYSTEM: 2019-10-30
• 00860000879804 - Sonon: 2019-02-21 Transducer, Ultrasonic, Diagnostic
• 00860000879811 - Sonon: 2019-02-21 System, Imaging, Pulse Echo, Ultrasonics
• 00860000879828 - Helcerion: 2019-02-21Transducer, Ultrasonic, Diagnostic
• 00860000879828 - Helcerion: 2019-02-21 Transducer, Ultrasonic, Diagnostic
• 00860000879835 - Sonon: 2019-02-21 System, Imaging, Pulsed Doppler, Ultrasonic
• 00860000879842 - Sonon: 2019-02-21 System, Imaging, Pulsed Echo, Ultrasonic