Multilink CS Catheter

GUDID 00850012226154

Cardionxt Inc

Cardiac mapping catheter, percutaneous, single-use

• Primary Device ID: 00850012226154
• NIH Device Record Key: e2052c19-9f27-4ce9-b662-7788672a23c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multilink CS Catheter
• Version Model Number: 821003
• Company DUNS: 117364041
• Company Name: Cardionxt 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: 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	00850012226154 [Primary]
GS1	10850012226151 [Package]; Package: Shipper Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201094

FDA Product Code

• DRF: Catheter, Electrode Recording, Or Probe, Electrode Recording

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-18
• Device Publish Date: 2025-12-10

Devices Manufactured by Cardionxt Inc

• 00850012226000 - Axis Patient Patches: 2025-12-18
• 00850012226154 - Multilink CS Catheter: 2025-12-18
• 00850012226154 - Multilink CS Catheter: 2025-12-18
• 00850012226291 - iMap 3D Mapping and Navigation System: 2025-12-18