UL_INJECT XD 8000

GUDID 04052536002245

XD 8000, ulrichINJECT CT motion composed of:

Ulrich GmbH & Co. KG

CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile CT contrast medium injection system, line-powered, mobile

• Primary Device ID: 04052536002245
• NIH Device Record Key: bb1918ab-848f-42f7-8765-bb4881b49850
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UL_INJECT
• Version Model Number: XD 8000
• Catalog Number: XD 8000
• Company DUNS: 315494757
• Company Name: Ulrich GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536002245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171392

FDA Product Code

• IZQ: Injector, contrast medium, automatic

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: 2019-03-20
• Device Publish Date: 2019-03-12

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