U7752P

GUDID 18054242446446

Disposable multifunction electrodes for defibrillation, synchronized cardioversion, transcutaneous cardiac stimulation and ECG monitoring, with direct connection to cables and defibrillators, provided with radiotransparent pads and radio-opaque cable. 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 PHYSIO-CONTROL. Paediatric version.

FIAB SPA

External defibrillator electrode, paediatric, single-use

• Primary Device ID: 18054242446446
• NIH Device Record Key: 323c76d9-721b-4c3f-ab43-4aca09ab576c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: U7752P
• Catalog Number: U7752P
• Company DUNS: 439770017
• Company Name: FIAB SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it
• Phone: +390558497943
• Email: quality@fiab.it

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054242446449 [Primary]
GS1	18054242446446 [Package]; Contains: 08054242446449; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103783

FDA Product Code

• LDD: Dc-Defibrillator, Low-Energy, (Including Paddles)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-20
• Device Publish Date: 2020-04-12

Devices Manufactured by FIAB SPA

• 08054751932464 - NA: 2025-08-04 HTC is a sterile bipolar battery operated disposable device for the cauterization of small vessels. It is used instead of a “
• 08033695726360 - NA: 2024-09-24 ECG patient cables USA version
• 08033003264676 - NA: 2024-03-27 Reusable ECG patient cables
• 08033695726414 - NA: 2023-10-17 ECG patient cables USA version
• 08058480757985 - NA: 2023-07-28 ECG patient cables USA version
• 38033695726514 - F3001ECG: 2023-02-24 Disposable solid gel tab electrode for ECG
• 18058480753984 - SENSITHERM MULTI: 2022-02-14 ST-PROBE-5 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm)
• 18058480753991 - SENSITHERM MULTI: 2022-02-14 ST-PROBE-7 is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm