AccessGUDID - DEVICE: NA (08054242449082)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: F9049/100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F9049/100
Company Name: FIAB SPA

Primary DI Number: 08054242449082
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 439770017 *Terms of Use

Device Description: Disposable ECG electrodes, oval-shaped 48x34mm dimensions with solid gel, Silver/Silver Chloride (SSC) sensor and stainless steel snap. F9049/100 model is suitable for rest, long term, stress or Holter ECG recording, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids.

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:	Yes
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?
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.	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 5 and 30 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: 80ed4058-6b4e-4b3e-95e7-8326cc49667a
Public Version Date: November 18, 2020
Public Version Number: 2
DI Record Publish Date: June 13, 2020