Ultrasound System, ZS3

GUDID 00851315007006

Diagnostic Ultrasound System

ZONARE MEDICAL SYSTEMS, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00851315007006
• NIH Device Record Key: 49846f03-9eff-4423-b624-35f9c7006db6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasound System, ZS3
• Version Model Number: ZS3
• 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	00851315007006 [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

On-Brand Devices [Ultrasound System, ZS3]

• 00851315007211: ZS3 - SP Diagnostic Ultrasound System
• 00851315007006: Diagnostic Ultrasound System