F3001ECG F3001ECG

GUDID 38033695726514

Disposable solid gel tab electrode for ECG

FIAB SPA

Electrocardiographic electrode, single-use

• Primary Device ID: 38033695726514
• NIH Device Record Key: cc80abdf-35dc-4e05-ad6e-46abc57a9db7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: F3001ECG
• Version Model Number: F3001ECG
• Catalog Number: F3001ECG
• Company DUNS: 439770017
• Company Name: FIAB SPA
• Device Count: 100
• 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: 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: 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
• 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 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033695726513 [Unit of Use]
GS1	38033695726514 [Primary]

FDA Product Code

• DRX: Electrode, Electrocardiograph

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: 2023-02-24
• Device Publish Date: 2023-02-16

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: 2023-02-24Disposable solid gel tab electrode for ECG
• 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