AngioTouch® Kit

GUDID 30841716102005

Model AT P65, p/n 701677-001 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing

ACIST MEDICAL SYSTEMS, INC.

Contrast medium injection system hand controller kit

• Primary Device ID: 30841716102005
• NIH Device Record Key: 5e26410d-d4b2-48af-9c4c-9d1385b95ea3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AngioTouch® Kit
• Version Model Number: 014645
• 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: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	10841716102001 [Primary]
GS1	30841716102005 [Package]; Contains: 10841716102001; Package: Shelf Box [10 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-09-16
• Device Publish Date: 2018-06-06

On-Brand Devices [AngioTouch® Kit]

• 30841716101930: Model AT P54, p/n 700608-054 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 10841716101394: Model AT P54, p/n 701278-008 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716100247: Model AT R54, p/n 700608-025 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716100230: Model AT P65, p/n 701564-001 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716100162: Model AT P54, p/n 700608-042 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716100148: Model AT P54, p/n 700608-040 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716100131: Model AT P54, p/n 700608-039 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716100094: Model AT L65, p/n 700608-026 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716101350: Model AT P54, p/n 700608-049 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716100223: Model AT P65, p/n 701554-002 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 10841716100199: Model AT P54, p/n 701278-006 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716100124: Model AT P54, p/n 700608-035 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716102135: Model AT P54, p/n 700608-055 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716102005: Model AT P65, p/n 701677-001 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716101992: Model AT P54, p/n 701675-001 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716101381: Model AT L65, p/n 700633-003 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716101374: Model AT R54, p/n 700632-003 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716101367: Model AT P65, p/n 701564-010 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716101312: Model AT P65, p/n 701564-008 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716101305: Model AT P54, p/n 700608-048 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716101299: Model AT P54, p/n 700608-047 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716101282: Model AT P54, p/n 700608-046 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716100780: Model AT P65, p/n 701564-002 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716100353: Model AT P54, p/n 700608-052 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716100216: Model AT P65, p/n 701554-001 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716100179: Model AT P54, p/n 701278-002 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 30841716100155: Model AT P54, p/n 700608-041 Kit Contents: hand controller, 3-way high-pressure stopcock with ro
• 10841716103251: Model AT X65L
• 10841716102421: Model AT X65