AccessGUDID - DEVICE: NA (08033003267684)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: F9010SSC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F9010SSC
Company Name: FIAB SPA

Primary DI Number: 08033003267684
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 439770017 *Terms of Use

Device Description: Reusable peripheral electrodes for ECG, 31.5x22mm dimensions, have features that make them absolutely reliable during signal recording with all different ECG recorders on the market. The metallic part is silver coated (Ag/AgCl) allowing a safe and clear signal transmission. F9010SSC thanks to screw and snap connections, can be tapped to all ECG recorders and monitors both with plug and snap. To be used with fasten belts.The product is Latex-free and Nickel-free.

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: c4cdb876-44d2-40ec-8e95-cc8857d740ad
Public Version Date: September 02, 2020
Public Version Number: 2
DI Record Publish Date: June 12, 2020