AcQMap

Basic Information

• Brand Name: AcQMap
• Primary DI: 00857042007029
• Version / Model: 900003
• Catalog Number: 900003
• Company Name: ACUTUS MEDICAL, INC.
• Labeler DUNS: 844418199
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-15
• Public Version: 4
• Public Version Date: 2021-10-11
• Public Version Status: Update
• Public Device Record Key: 3fb126df-b75f-406e-87d4-86a0a6e5a54f

Device Description

AcQMap® 3D Imaging & Mapping Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MTD	Catheter,Intracardiac Mapping,High-Density Array	Cardiovascular	870.1220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62545	Cardiac mapping/ultrasound imaging catheter	A sterile, flexible, dual-purpose tube containing an arrangement of electrodes and ultrasonic imaging transducers at its distal tip, designed for: 1) electrophysiological diagnostic examinations such as electrophysiology (EP) mapping, sensing, and recording of cardiac structures; and 2) intracardiac ultrasound for visualization of the cardiac anatomy (inner surface), primarily to support the EP functions. It is introduced percutaneously through a compatible steerable guide catheter (not included) to enable manoeuvring within the cardiac anatomy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857042007029	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]