128599565 901528

GUDID 00818083011338

Fixed, 10 electrode, CS, 2mm electrode spacing

ACCESS POINT TECHNOLOGIES, INC.

Catheter-tip electrode Catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode

• Primary Device ID: 00818083011338
• NIH Device Record Key: 940c976f-2b37-4f28-9158-2134b12d2079
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 128599565
• Version Model Number: 901528
• Catalog Number: 901528
• Company DUNS: 128599565
• Company Name: ACCESS POINT TECHNOLOGIES, 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 Dimensions

• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Catheter Gauge: 5 French
• Length: 120 Centimeter
• Catheter Gauge: 5 French
• Length: 120 Centimeter
• Catheter Gauge: 5 French
• Length: 120 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818083011338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160390

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: 2018-11-20
• Device Publish Date: 2018-10-20

Devices Manufactured by ACCESS POINT TECHNOLOGIES, INC.

• 00818083014001 - Map-iT: 2019-07-03 Fixed, 10 electrode, S, 2-8-2mm electrode spacing, Guidewire Tip
• 00818083015909 - Map-iT: 2019-07-03 STR, 4 electrode, MPD-DL, 5mm electrode spacing
• 00818083015947 - Map-iT: 2019-07-03 STR, 4 electrode, MPD-S, 2mm electrode spacing
• 00818083015954 - Map-iT: 2019-07-03 STR, 4 electrode, MPD-S, 5mm electrode spacing
• 00818083015961 - Map-iT: 2019-07-03 STR, 4 electrode, MPD-SL, 2mm electrode spacing
• 00818083015978 - Map-iT: 2019-07-03 STR, 4 electrode, MPD-SL, 5mm electrode spacing
• 00818083015985 - Map-iT: 2019-07-03 STR, 4 electrode, MPD-CS-S, 2-5-2mm electrode spacing
• 00818083016005 - Map-iT: 2019-07-03 STR, 4 electrode, MPD-CS-S, 2mm electrode spacing