AFFINITI CVX DIAGNOSTIC ULTRASOUND SYSTEM

GUDID 00884838101043

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system

• Primary Device ID: 00884838101043
• NIH Device Record Key: 471bbbf1-a797-4184-bfba-10c4dec257c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFFINITI CVX DIAGNOSTIC ULTRASOUND SYSTEM
• Version Model Number: 795190
• 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: 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	00884838101043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201012

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: 2020-08-24
• Device Publish Date: 2020-08-14

On-Brand Devices [AFFINITI CVX DIAGNOSTIC ULTRASOUND SYSTEM]

• 00884838101043: 795190
• 00884838114166: Software version- 10.0.X
• 00884838123984: VM11.0 update