AccessGUDID - DEVICE: NA (08054242441888)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: U7955P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U7955P
Company Name: FIAB SPA

Primary DI Number: 08054242441888
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 439770017 *Terms of Use

Device Description: Disposable multifunction electrodes for external defibrillation, transthoracic synchronized cardioversion, transcutaneous cardiac stimulation and ECG monitoring. Designed for direct connection to cables and defibrillators, they are characterized by a low impedance and a reduced stimulation threshold, with an excellent adaptability to the patient’s skin. The protective foam insulator and the safety plug eliminate every risk of electric micro-shock. Electrodes equipped with connector for defibrillators NIHON KOHDEN.Data Paediatric version.

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":	No
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?
41587	External defibrillation electrode, paediatric, single-use	An electrical conductor intended to be used in pairs to transmit a controlled electrical shock from an external defibrillator to a pre-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with self-affixing pads (the electrodes) prefabricated with contact gel and an adhesive, that are applied to the chest (the intact torso) or back of the patient so that the discharge passes across the region of the heart. This device may remain applied to the patient during stages of treatment. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103783	000

Device Exempt from Premarket Submission: No 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 Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 35 Degrees Celsius
Storage Environment Temperature: between 41 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d04df654-8b09-4e59-9a7d-1e057f2178d3
Public Version Date: July 06, 2023
Public Version Number: 2
DI Record Publish Date: April 12, 2020