SmartPerfusion 001119

GUDID 00884838088566

Software medical device used with a Philips Interventional X-Ray System. Provides color coded representation of digital subtraction angiography to assist diagnosis of perfusion alterations of tissues.

Philips Medical Systems Nederland B.V.

Angiographic x-ray system application software

• Primary Device ID: 00884838088566
• NIH Device Record Key: f97b8a45-dab0-4bc8-8e5c-60bfc52417ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartPerfusion
• Version Model Number: SmartPerfusion R1
• Catalog Number: 001119
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838088566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181966

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2019-10-24
• Device Publish Date: 2018-11-19

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