ARTIS icono ceiling

GUDID 04056869295923

Siemens Healthcare GmbH

Stationary angiographic x-ray system, digital

• Primary Device ID: 04056869295923
• NIH Device Record Key: 1952e8d3-e694-42a5-8f72-526399481f6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTIS icono ceiling
• Version Model Number: 11328100
• Company DUNS: 313217003
• Company Name: Siemens Healthcare GmbH
• 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

Customer Support Contacts

• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056869295923 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221516

FDA Product Code

• IZI: System, x-ray, angiographic

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: 2022-10-10
• Device Publish Date: 2022-10-01

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