Ultrasonix Medical Corporation

GUDID 08294362400024

SonixONE Ultrasound System

ANALOGIC CORPORATION

General-purpose ultrasound imaging system

• Primary Device ID: 08294362400024
• NIH Device Record Key: 6efa087a-29a4-4d4b-81d0-ed62da22fad2
• Commercial Distribution Discontinuation: 2019-08-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ultrasonix Medical Corporation
• Version Model Number: 24.000.100
• Company DUNS: 019677418
• Company Name: ANALOGIC CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: 1-604-279-8550
• Email: techsupport@bkultrasound.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08294362400024 [Primary]

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, 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: 2020-01-28
• Device Publish Date: 2017-11-17

On-Brand Devices [Ultrasonix Medical Corporation]

• 08294362400024: SonixONE Ultrasound System
• 08294362400000: SonixTABLET Ultrasound System
• 08294362200020: SonixSP Q+Ultrasound System
• 08294362200006: SonixSP Ultrasound System
• 08294362100023: SonixOP Q+ Ultrasound System
• 08294362100009: SonixOP Ultrasound System
• 08294362000026: SonixMDP Q+ Ultrasound System
• 08294362000002: SonixMDP Ultrasound System
• 08294361800023: SonixTOUCH Q+ Ultrasound System
• 08294361800009: SonixTOUCH Ultrasound System
• 08294360350840: SA4-2/24 Phased Array Transducer
• 08294360350819: Linear Transducer for - Abdominal, Musculoskeletal, Nerve Block, Pediatric and Small Parts
• 08294360350772: L9-4 /38 Linear Transducer
• 08294360350734: L40-8/12, High frequency Linear Transducer
• 08294360350727: PA7-4/12, Phased Array Transducer
• 08294360350710: 4DC7-3/40, 4D motor-driven electronic Convex Transducer
• 08294360350697: 4DL14-5/38 Linear transducer
• 08294360350666: C5-2/60 Convex Transducer
• 08294360350642: L14-5/38 GPS Linear Transducer
• 08294360350635: C5-2/60 GPS Convex Transducer
• 08294360350611: C7-3/50 Convex Transducer
• 08294360350604: 4DEC9-5/10, 4D motor-driven electronic Endocavity Microconvex Transducer
• 08294360350581: MC9-4 Microconvex transducer
• 08294360350567: HST 15-8/20, Linear Transducer
• 08294360350499: EC9-5/10 Endocavity Microconvex Transducer
• 08294360350352: Linear Wide Transducer for - Abdominal, Musculoskeletal, Nerve Block, Pediatric and Small Parts
• 08294360246341: SonixONE Cart
• 08294360350536: BPC8-4/10 Microconvex BPL9-5/55 Linear Biplane Transducer