Affera™ Integrated Mapping System

Basic Information

• Brand Name: Affera™ Integrated Mapping System
• Primary DI: 00763000998271
• Version / Model: AFR-00016
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-22
• Public Version: 1
• Public Version Date: 2025-09-01
• Public Version Status: New
• Public Device Record Key: 170bea07-65ae-4d7d-a914-58b7833178a7

Device Description

MAP SYS AFR-00016 IMPEDANCE US PLX

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: Yes
• Has Lot/Batch Number: No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
46265	Cardiac mapping system	An assembly of devices designed to measure, process, and store electronic data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices (e.g., body surface or intracardiac electrocardiograph (ECG) sensors, transducers, and catheters). The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. It typically consists of dedicated workstation, hardware and software that display real-time, three-dimensional (3-D) cardiac maps (e.g., electrical propagation, electrical potential, and cardiac chamber geometry maps), and a catheter.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000998271	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K243892	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius