Affiniti 30 Ultrasound System

GUDID 00884838124974

Affiniti 30 Ultrasound System VM 12.0

Philips Ultrasound LLC

General-purpose ultrasound imaging system

• Primary Device ID: 00884838124974
• NIH Device Record Key: 395a15d0-365f-4075-997a-fbbafbd91e23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affiniti 30 Ultrasound System
• Version Model Number: 795218
• 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: 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	00884838124974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242020

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: 2024-12-27
• Device Publish Date: 2024-12-19

Devices Manufactured by Philips Ultrasound LLC

• 00884838126893 - EPIQ Diagnostic Ultrasound System Circular Edition: 2025-07-01 EPIQ CVx Diagnostic Ultrasound System Circular Edition
• 00884838126909 - Affiniti CVx Diagnostic Ultrasound System: 2025-07-01 Affiniti CVx Diagnostic Ultrasound System
• 00884838126923 - EPIQ Diagnostic Ultrasound System: 2025-07-01 EPIQ CVx Diagnostic Ultrasound System
• 00884838126930 - EPIQ Diagnostic Ultrasound System: 2025-07-01 EPIQ CVxi Diagnostic Ultrasound System
• 00884838126947 - Affiniti CVx Diagnostic Ultrasound System Circular Edition: 2025-07-01 Affiniti CVx Diagnostic Ultrasound System Circular Edition
• 00884838115354 - Ultrasound System 5100 POC: 2025-05-29 Flash Ultrasound System 5100 POC, release 1.0.
• 00884838120174 - Ultrasound System 5100 POC Pro: 2025-05-29 Flash Ultrasound System 5100 POC, release 1.0.
• 00884838125186 - Ultrasound Workspace: 2025-04-01