ulricheasyINJECT Max

GUDID 04052536205479

ulricheasyINJECT Max 3

Ulrich GmbH & Co. KG

MRI contrast medium injection system, line-powered, mobile

• Primary Device ID: 04052536205479
• NIH Device Record Key: eda33dee-a292-44f2-8354-91f2eb4a53c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ulricheasyINJECT Max
• Version Model Number: XD 10150
• Company DUNS: 315494757
• Company Name: Ulrich GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536205479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233737

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: 2024-06-06
• Device Publish Date: 2024-05-29

On-Brand Devices [ulricheasyINJECT Max]

• 04052536205493: ulricheasyINJECT Max 2M
• 04052536205479: ulricheasyINJECT Max 3
• 04052536205363: ulricheasyINJECT Max 3