AcQMap

Basic Information

• Brand Name: AcQMap
• Primary DI: 00850027837239
• Version / Model: 800696
• Catalog Number: 800696
• Company Name: ACUTUS MEDICAL, INC.
• Labeler DUNS: 844418199
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-01
• Public Version: 1
• Public Version Date: 2022-02-09
• Public Version Status: New
• Public Device Record Key: e4975a6b-fc00-4d6e-a9c0-67ac5aeb3e0d

Device Description

AcQMap to SmartAblate Generator Adapter

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQK	Computer, Diagnostic, Programmable	Cardiovascular	870.1425	2
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35041	Electrosurgical cable adaptor	A small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850027837239	GS1

Customer Contacts

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