F9024ULTRA

GUDID 08033003261552

Reusable peripheral clamp electrodes for ECG, 30x130mm clamp dimensions. F9024ULTRA has features that make it absolutely reliable during signal recording with all different ECG devices on the market.The electrode plastc part is made of silver coated material, allowing a safe and clear signal transmission.The treatment allows the recovery of the signal after defibrillation discharge in compliance with EN60601-2-25 regulation. FIAB peripheral electrodes, thanks to screw and clip connections, can be connected to all ECG devices and monitors with patient cable which have plug or snap connections. The product is latex-free and Nickel-free.

FIAB SPA

Electrocardiographic electrode, reusable

• Primary Device ID: 08033003261552
• NIH Device Record Key: 4cde7561-eb69-42e8-a5fc-b4232f51fc77
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: F9024ULTRA
• Catalog Number: F9024ULTRA
• Company DUNS: 439770017
• Company Name: FIAB SPA
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033003261552 [Primary]
GS1	78033003261551 [Unit of Use]

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-09-02
• Device Publish Date: 2020-06-12

Devices Manufactured by FIAB SPA

• 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
• 08058480754021 - SENSITHERM MULITI: 2022-02-14 ST-MONITOR is a device for monitoring of esophageal temperature on three different points; moreover it allows setting of temper