F9011PG

GUDID 78033003267423

F9011PG is rubber belts used to fix limb electrodes for ECG. The rubber belt is made of biocompatible natural rubber, without additives and not irritating. Width 24 +/- 1 mm Length 48 +/-0.5 cm

FIAB SPA

Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable Electrode/transducer strap, reusable
Primary Device ID78033003267423
NIH Device Record Key10bbd561-8837-4afb-b05d-8176a1d122b8
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberF9011PG
Catalog NumberF9011PG
Company DUNS439770017
Company NameFIAB SPA
Device Count4
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108033003267424 [Primary]
GS178033003267423 [Unit of Use]

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

Devices Manufactured by FIAB SPA

08033003267417 - NA2021-04-08 F9011P is a rubber belts used to fix limb electrodes for ECG.The rubber belt is made of biocompatible natural rubber, without ad
78033003267423 - NA2021-04-08F9011PG is rubber belts used to fix limb electrodes for ECG. The rubber belt is made of biocompatible natural rubber, without additives and not irritating. Width 24 +/- 1 mm Length 48 +/-0.5 cm
78033003267423 - NA2021-04-08 F9011PG is rubber belts used to fix limb electrodes for ECG. The rubber belt is made of biocompatible natural rubber, without ad
18033695724851 - NA2021-04-08 Disposable ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG
08054242447798 - NA2021-02-19 PG471W/US are disposable adhesive electrodes with solid conductive gel. High material flexibility permits to apply electrodes ve
08054242447804 - NA2021-02-19 PG474W/US are disposable adhesive electrodes with solid conductive gel. High material flexibility permits to apply electrodes ve
08054242447811 - NA2021-02-19 PG471/50W/US are round shaped-disposable adhesive electrodes with solid conductive gel. High material flexibility permits to app
08054242447828 - NA2021-02-19 PG479/50W/US are round-shaped disposable adhesive electrodes with solid conductive gel. High material flexibility permits to app
08054242447835 - NA2021-02-19 PG479/75W/US are round-shaped disposable adhesive electrodes with solid conductive gel. High material flexibility permits to app

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