CVi® Cable

GUDID 30841716102036

CVi Medex Spacelabs cable, p/n 300501-001

ACIST MEDICAL SYSTEMS, INC.

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

• Primary Device ID: 30841716102036
• NIH Device Record Key: 0dfbedf2-99f4-452c-b0f8-7dc161af3470
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CVi® Cable
• Version Model Number: 015636
• Company DUNS: 926684994
• Company Name: ACIST MEDICAL SYSTEMS, INC.
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30841716102036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171646

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-06-05

On-Brand Devices [CVi® Cable]

• 30841716102036: CVi Medex Spacelabs cable, p/n 300501-001
• 30841716101138: CVi interface cable, p/n 700709-006
• 30841716101121: CVi interface cable, p/n 700709-005
• 30841716101114: CVi cable, p/n 700658-004
• 30841716101107: CVi cable, p/n 700658-003
• 30841716101091: CVi cable, p/n 700658-002
• 30841716101084: CVi cable, p/n 700658-001
• 30841716101077: CVi interface cable, p/n 700402-003
• 30841716101060: CVi interface cable, p/n 700402-002
• 30841716101053: CVi interface cable, p/n 700385-004
• 30841716101046: CVi interface cable, p/n 700318-003
• 30841716100995: CVi controller interface cable, p/n 301188-001
• 30841716100988: CVi controller interface cable, p/n 301179-001
• 30841716100971: CVi hemodynamic cable, p/n 300874-001
• 30841716100964: CVi single channel transducer cable, p/n 300814-001
• 30841716100957: CVi ground cord, p/n 300542-001
• 30841716100940: CVi cable, p/n 300522-001
• 30841716100933: CVi hemodynamic cable, p/n 300521-001
• 30841716100926: CVi cable, p/n 300520-001
• 30841716100919: CVi cable, p/n 300506-001
• 30841716100902: CVi cable, p/n 300505-001
• 30841716100896: CVi cable, p/n 300504-001
• 30841716100889: CVi cable, p/n 300498-001
• 30841716100872: CVi cable, p/n 300496-001
• 30841716100865: CVi cable, p/n 300495-001
• 30841716100858: CVi single channel transducer cable, p/n 300459-001
• 30841716100841: CVi single channel transducer cable, p/n 300457-001
• 30841716100834: CVi single channel transducer cable, p/n 300456-001
• 30841716100827: CVi single channel transducer cable, p/n 300455-001
• 30841716100810: CVi single channel transducer cable, p/n 300453-001