NA

Basic Information

• Brand Name: NA
• Primary DI: 08054953341248
• Version / Model: F2017/4FL
• Catalog Number: F2017/4FL
• Company Name: FIAB SPA
• Labeler DUNS: 439770017
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• 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: 77c65c8f-dbf1-4674-aef7-52f03985205a

Device Description

Disposable oval-shaped ECG electrodes with liquid gel, Silver/Silver Chloride(SSC) sensor, 52x32mm dimensions and with 4mm socket . These electrodes dimensions have features that make them absolutely reliable during signal recording in rest tests, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording and off-centered configuration allows a better quality of ECG signal and reduces artifacts. They comply with ANSI/AAMI EC12:2000 permitting the signal recovery after defibrillator discharge. After opening, the pouch can be folded to ensure a better preservation of the electrodes that remain inside. The products are latex-free.

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: 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
35035	Electrocardiographic electrode, single-use	A non-sterile, 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, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18054953341245	GS1		15	In Commercial Distribution
Primary	08054953341248	GS1
Package	28054953341242	GS1		6	In Commercial Distribution
Unit of Use	78054953341247	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 20 – 80 Percent (%) Relative Humidity