EPIQ Elite Diagnostic Ultrasound System

GUDID 00884838127128

EPIQ Elite Diagnostic Ultrasound System Circular Edition, VM12.0

Philips Ultrasound LLC

General-purpose ultrasound imaging system

• Primary Device ID: 00884838127128
• NIH Device Record Key: 909527d7-3e51-4708-a71d-73f56f285653
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIQ Elite Diagnostic Ultrasound System
• Version Model Number: 795125
• Company DUNS: 063377717
• Company Name: Philips Ultrasound LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	00884838127128 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-16
• Device Publish Date: 2026-01-08

On-Brand Devices [EPIQ Elite Diagnostic Ultrasound System]

• 00884838124912: EPIQ Elite Diagnostic Ultrasound System VM 12.0.
• 00884838127128: EPIQ Elite Diagnostic Ultrasound System Circular Edition, VM12.0