Affiniti 50 Diagnostic Ultrasound System

GUDID 00884838056244

Affiniti 50 Diagnostic Ultrasound System

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system

• Primary Device ID: 00884838056244
• NIH Device Record Key: 520e6285-1df8-4db5-84e3-2c155faee5ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affiniti 50 Diagnostic Ultrasound System
• Version Model Number: 989605410251
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838056244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132304

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-12
• Device Publish Date: 2016-03-31

On-Brand Devices [Affiniti 50 Diagnostic Ultrasound System]

• 00884838056244: Affiniti 50 Diagnostic Ultrasound System
• 00884838114173: Software version - 10.0.X