NA

Basic Information

• Brand Name: NA
• Primary DI: 08033003261569
• Version / Model: F9016ULTRA
• Catalog Number: F9016ULTRA
• Company Name: FIAB SPA
• Labeler DUNS: 439770017
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2020-06-12
• Public Version: 2
• Public Version Date: 2020-11-11
• Public Version Status: Update
• Public Device Record Key: b60c9f1f-ab94-43cf-bcc7-0d5ed88905d2

Device Description

Reusable praecordial suction chest electrodes for ECG, rubber ring diameter Ø 30mm and electrode diameter Ø 14mm. F9016ULTRA model has features that make it absolutely reliable during signal recording with all different ECG devices on the market. The plastic metallic part is silver coated (Ag/AgCl) allowing a safe and clear signal transmission.The treatment allows the recovery of the signal after defibrillation discharge in compliance with EN60601-2-25 regulation. FIAB suction chest electrodes thanks toelastic connections, can be tapped to all ECG devices and monitors with patient cables which have 4mm plug connections. The product is Latex-free and Nickel-free.

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRX	Electrode, Electrocardiograph	Cardiovascular	870.2360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42489	Electrocardiographic electrode, reusable	A noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, or adhesive tape, and a conductive gel (some are pre-gelled), or using a suction mechanism; alternatively, some types may be designed to be attached to hand-held heart rate meters. Electrocardiography (ECG) is usually performed using a set of electrodes (e.g., 12) connected to appropriate leads and cables. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08033003261569	GS1
Unit of Use	78033003261568	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 20 – 80 Percent (%) Relative Humidity