DAR-8000i

GUDID 04540217011469

SHIMADZU CORPORATION

Stationary angiographic x-ray system, digital

• Primary Device ID: 04540217011469
• NIH Device Record Key: aa1f1bff-6d38-4b00-83c0-52abe2f83dc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DAR-8000i
• Version Model Number: 502-24400-12
• Company DUNS: 690558747
• Company Name: SHIMADZU CORPORATION
• 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: true
• 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	04540217011469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052076

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [DAR-8000i]

• 04540217011469: 502-24400-12
• 04540217011452: 502-24400-11