NA

Basic Information

• Brand Name: NA
• Primary DI: 08033695723369
• Version / Model: F9069RM
• Catalog Number: F9069RM
• Company Name: FIAB SPA
• Labeler DUNS: 439770017
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• 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: 4316a583-be11-4a6b-be90-922a9e12098e

Device Description

F9069RM model is disposable ECG RADIOLUCENT electrode with solid gel, oval-shaped 42x45mm, Silver/Silver Chloride (SSC) sensor and carbon snap. The SSC sensor permits a reliable and stable recording. The peculiar feature of the electrode is the carbon snap that makes it radiolucent. Neither of the components contains any ferromagnetic materials, therefore the electrodes are fully compatible with MRI applications. The electrodes are MRI tested for use up to 3 T electro-magnetic field. The use of the electrodes do not affect the safety and functioning of Magnetic Resonance Imaging Systems. 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	38033695723360	GS1		24	In Commercial Distribution
Primary	08033695723369	GS1
Package	48033695723367	GS1		10	In Commercial Distribution
Unit of Use	78033695723368	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