TOMTEC ARENA

GUDID 00884838124233

Philips Ultrasound LLC

Radiological PACS software

• Primary Device ID: 00884838124233
• NIH Device Record Key: 6b471d92-a672-4d4b-af3a-cacfa42145ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOMTEC ARENA
• Version Model Number: TTA2.53
• Company DUNS: 063377717
• Company Name: Philips Ultrasound LLC
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838124233 [Primary]

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2024-07-11
• Device Publish Date: 2024-07-03

Devices Manufactured by Philips Ultrasound LLC

• 00884838100213 - Transducer C5-1: 2024-08-07 Introduction of C5-1 (Shanghai Version) to rest of the world.
• 00884838124233 - TOMTEC ARENA: 2024-07-11
• 00884838124233 - TOMTEC ARENA: 2024-07-11
• 00884838125674 - Affiniti CVx Diagnostic Ultrasound System Circular Edition: 2024-06-20 VM 11.0 update
• 00884838125643 - EPIQ CVx Diagnostic Ultrasound System Circular Edition: 2024-06-11 VM11.0 update
• 00884838125650 - EPIQ 7 Diagnostic Ultrasound System Circular Edition: 2024-06-11 VM11.0 update
• 00884838125667 - Affiniti 70 Diagnostic Ultrasound System Circular Edition: 2024-06-11 VM11.0 update