Ultrasound System, Z.One PRO

GUDID 00851315007013

Diagnostic Ultrasound System

ZONARE MEDICAL SYSTEMS, INC.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 00851315007013
• NIH Device Record Key: 10dd6d59-90f4-4208-8a0e-98675483031f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasound System, Z.One PRO
• Version Model Number: Z.One PRO
• Company DUNS: 096113340
• Company Name: ZONARE MEDICAL SYSTEMS, 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	00851315007013 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-05-23
• Device Publish Date: 2016-09-23

Devices Manufactured by ZONARE MEDICAL SYSTEMS, INC.

• 00851315007006 - Ultrasound System, ZS3: 2018-05-23 Diagnostic Ultrasound System
• 00851315007013 - Ultrasound System, Z.One PRO: 2018-05-23Diagnostic Ultrasound System
• 00851315007013 - Ultrasound System, Z.One PRO: 2018-05-23 Diagnostic Ultrasound System
• 00851315007020 - L10-5 Linear Array Transducer: 2018-05-23 L10-5 Linear Array Diagnostic Ultrasonic Transducer
• 00851315007037 - E9-4 Endocavity Transducer: 2018-05-23 E9-4 Endocavity Diagnostic Ultrasonic Transducer
• 00851315007044 - L8-3 Linear Array Transducer: 2018-05-23 L8-3 Linear Array Diagnostic Ultrasound Transducer
• 00851315007051 - L14-5sp Linear Array Transducer: 2018-05-23 L14-5sp Linear Array Diagnostic Ultrasound Transducer
• 00851315007068 - P4-1c Phased Array Transducer: 2018-05-23 P4-1c Phased Array Diagnostic Ultrasound Transducer
• 00851315007075 - C9-3 Curved Array Transducer: 2018-05-23 C9-3 Curved Array Diagnostic Ultrasonic Transducer