Touch Prime Ultrasound System 1738830

GUDID 60889971738837

XE Edition

CARESTREAM HEALTH, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 60889971738837
• NIH Device Record Key: e4171765-8bd0-47fe-a12a-8209eb1284f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Touch Prime Ultrasound System
• Version Model Number: Touch Prime Ultrasound System
• Catalog Number: 1738830
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, 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: false
• 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	60889971738837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150342

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-01
• Device Publish Date: 2016-09-16

On-Brand Devices [Touch Prime Ultrasound System]

• 60889971738837: XE Edition
• 60889971738820: Touch Prime Ultrasound System