FDA.reportPublic FDA data

NA

Primary DI
08033695725318
Brand
NA
Company
FIAB SPA
Model
F9047/4F
Catalog number
F9047/4F
Device description
F9047/4F model is ECG disposable pregelled electrode with liquid, 28x44mm dimensions, SSC sensor and adapter for 4mm plug connection. The ECG electrode have features that make them absolutely reliable during signal recording. F9047/4F model is used also recording in stress test and for Holter monitoring.
Published
2020-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28033695725312PackageGS120In Commercial Distribution
38033695725319PackageGS110In Commercial Distribution
08033695725318PrimaryGS10
78033695725317Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2803369572531228033695725312
3803369572531938033695725319
08033695725318080336957253188033695725318
7803369572531778033695725317

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+39 0558497943quality@fiab.it

Regulatory Flags#

DUNS number
439770017
Device count
50
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054242441765NAU7951U79512020-04-12
08054242441772NAU7952U79522020-04-12
08054242441789NAU7955U79552020-04-12
08054242441796NAU7961U79612020-04-12
08054242441802NAU7750U77502020-04-12
08054242441819NAU7751U77512020-04-12
08054242441826NAU7752U77522020-04-12
08054242441833NAU7755U77552020-04-12
08054242441840NAU7761U77612020-04-12
08054242444933NAU7959U79592020-04-12
08054242441758NAU7950U79502020-04-12
08054751932464NAF7266F72662025-07-27
08033695726360NAF6738RAHAF6738RAHA2024-09-16
28058480756401NAF7244F72442024-09-05
28058480757415NAF7255F72552024-09-05
18033695727142NAF7244F72442020-05-14
18033695727159NAF7255F72552020-05-14
18033695727166NAF7277F72772020-05-14
18033695727456NAF7244/1F7244/12020-05-14
08033695726414NAF6748RAHAF6748RAHA2023-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
08033003267424NAFIAB SPADRX2021-03-31
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08906035283079Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283086Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283093Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283109Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283123Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20