iE33 Diagnostic Ultrasound System

GUDID 00884838025226

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system

• Primary Device ID: 00884838025226
• NIH Device Record Key: 605da96c-5f54-42ef-a039-16ec72f2ab51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iE33 Diagnostic Ultrasound System
• Version Model Number: 8500-0082-01
• Company DUNS: 063377717
• Company Name: Philips Ultrasound, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838025226 [Primary]

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: 2018-11-12
• Device Publish Date: 2016-08-25

Devices Manufactured by Philips Ultrasound, Inc.

• 00884838102729 - Transducer X11-4t: 2024-04-11
• 00884838115323 - QLAB Advanced Quantification Software: 2024-04-11
• 00884838122116 - Lumify Diagnostic Ultrasound System: 2024-04-08 Android 5.0
• 00884838120266 - Lumify Diagnostic Ultrasound System iOS: 2023-08-08 Release 5.0 iOS
• 00884838121423 - TOMTEC ARENA: 2023-07-27
• 00088483810859 - Transducer mL26-8: 2023-05-30
• 00884838114128 - EPIQ 5W Diagnostic Ultrasound System: 2023-05-18 Software version-10.0.X
• 00884838114111 - EPIQ 5 Diagnostic Ultrasound System: 2023-05-17 Software version-10.0.X