NA

Basic Information

• Brand Name: NA
• Primary DI: 08033003261675
• Version / Model: F9053P
• Catalog Number: F9053P
• 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: 2020-11-11
• Public Version Status: Update
• Public Device Record Key: e4090d29-3ab7-4410-b359-91e32c3e7410

Device Description

Disposable ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9053P model is oval-shaped electrodes, 23x30mm dimensions, equipped with 35cm long wire and 4mm socket, pre-gelled and they can be easily connected to the ECG monitor, avoiding pressure on the skin. Pediatric model.

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
Primary	08033003261675	GS1
Package	18033003261672	GS1		5	In Commercial Distribution
Unit of Use	78033003261674	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