NA

Basic Information

• Brand Name: NA
• Primary DI: 08054242444650
• Version / Model: F9008SSC/RU
• Catalog Number: F9008SSC/RU
• Company Name: FIAB SPA
• Labeler DUNS: 439770017
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2020-06-13
• Public Version: 2
• Public Version Date: 2020-11-11
• Public Version Status: Update
• Public Device Record Key: c3dc0d8c-7bc2-42bd-a681-acf2a90e5818

Device Description

Reusable praecordial suction chest electrodes for ECG, metallic part Ø 15mm and ball diameter Ø 25mm. F9008SSC/RU model has features that make itabsolutely reliable during signal recording with all different ECG devices on the market. The metallic part is silver and silver chloride (Ag/AgCl) allowing a safe and clear signal transmission. FIAB suction chest electrodes, thanks to screw and clip connections, can be tapped to all ECG devices and monitors with patient cables which have plug or snap connections.

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	08054242444650	GS1
Unit of Use	78054242444659	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