NA

Basic Information

• Brand Name: NA
• Primary DI: 08054953341064
• Version / Model: F9057PRM
• Catalog Number: F9057PRM
• Company Name: FIAB SPA
• Labeler DUNS: 439770017
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• 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: 338a21fb-fb57-4e8a-875c-b3133bab37fa

Device Description

F9057PRM model is a disposable round-shaped ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9057PRM is pre-gelled, Ø 32mm, equipped with 50cm long wire and DIN 42802-1 1.5mm socket. The external surface is made of non woven fabric. The fabric is made of plastic polyethylene fiber (and not natural fiber) that guarantees the transpiration of the skin, but at the same time the resistance to liquids with which they may come into contact during their use. Adult and Pediatric model. F9057PRM model is radiotranslucent, therefore it allows the user to perform radiographic procedures without removing the electrode.

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	18054953341061	GS1		50	In Commercial Distribution
Primary	08054953341064	GS1
Unit of Use	78054953341063	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