NA

Basic Information

• Brand Name: NA
• Primary DI: 08054242449921
• Version / Model: F9053N/55
• Catalog Number: F9053N/55
• Company Name: FIAB SPA
• Labeler DUNS: 439770017
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2020-06-13
• Public Version: 2
• Public Version Date: 2020-11-18
• Public Version Status: Update
• Public Device Record Key: 82070580-30fd-44cd-b6be-b08539178f33

Device Description

Disposable ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9053N/55 model is oval-shaped electrodes, 30x23mm dimensions, equipped with 55cm long wire and 4mm socket, pre-gelled and it can be easily connected to the ECG monitor, avoiding pressure on the skin. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids.

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	18054242449928	GS1		5	In Commercial Distribution
Primary	08054242449921	GS1
Unit of Use	78054242449920	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