Transducer X11-4t

GUDID 00884838102729

Philips Ultrasound, Inc.

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• Primary Device ID: 00884838102729
• NIH Device Record Key: 8dd022c2-26fa-4087-8c48-58dde841004c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transducer X11-4t
• Version Model Number: 989605501821
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838102729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233545

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: 2024-04-11
• Device Publish Date: 2024-04-03

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• 00884838114234 - EPIQ Elite Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition
• 00884838102729 - Transducer X11-4t: 2024-04-11
• 00884838102729 - Transducer X11-4t: 2024-04-11
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• 00884838120266 - Lumify Diagnostic Ultrasound System iOS: 2023-08-08 Release 5.0 iOS