ACIST CVi®1 Contrast Delivery System Injector Head

GUDID 10841716102209

CVi1 Injector (Siemens), p/n 700708-011

ACIST MEDICAL SYSTEMS, INC.

Angiography contrast medium injection system, line-powered, mobile

• Primary Device ID: 10841716102209
• NIH Device Record Key: e3d265fd-6473-45c7-a2bb-698c01a6a0f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIST CVi®1 Contrast Delivery System Injector Head
• Version Model Number: 016671
• Company DUNS: 926684994
• Company Name: ACIST MEDICAL SYSTEMS, INC.
• 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: 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	10841716102209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191060

FDA Product Code

• DXT: Injector And Syringe, 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: 2019-10-25
• Device Publish Date: 2019-10-17

On-Brand Devices [ACIST CVi®1 Contrast Delivery System Injector Head]

• 10841716102209: CVi1 Injector (Siemens), p/n 700708-011
• 10841716102193: CVi1 Injector, p/n 700706-011