AccessGUDID - DEVICE: NA (08033003263303)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: F9016NI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F9016NI
Company Name: FIAB SPA

Primary DI Number: 08033003263303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 439770017 *Terms of Use

Device Description: Reusable praecordial suction chest electrodes for ECG, metallic part diameter Ø 30mm and ball diameter Ø 33mm. F9016NI model has features that make it absolutely reliable during signal recording with all different ECG devices on the market. The metallic part is nickel plated 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRX	Electrode, Electrocardiograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: between 20 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 69e323b3-8d16-4cc8-8975-3ed07220f834
Public Version Date: August 31, 2020
Public Version Number: 2
DI Record Publish Date: June 12, 2020