Affiniti 30 Ultrasound System

GUDID 00884838106628

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system

• Primary Device ID: 00884838106628
• NIH Device Record Key: 49aa5bb3-f60e-4b2b-881e-1f531d2e7877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affiniti 30 Ultrasound System
• Version Model Number: 795218
• 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	00884838106628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211597

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2021-09-29
• Device Publish Date: 2021-09-21

On-Brand Devices [Affiniti 30 Ultrasound System]

• 00884838097957: 795218
• 00884838106628: 795218