F6237AHA

GUDID 08058480757985

ECG patient cables USA version

FIAB SPA

Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor Electrocardiographic lead switching adaptor
Primary Device ID08058480757985
NIH Device Record Keye038a7dd-948e-45c5-9ec0-9559f38a146d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberF6237AHA
Catalog NumberF6237AHA
Company DUNS439770017
Company NameFIAB SPA
Device Count1
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 Latexfalse
Labeled No Natural Rubber Latextrue
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
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
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
GS108058480757985 [Primary]

FDA Product Code

IKDCable, Electrode

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-28
Device Publish Date2023-07-20

Devices Manufactured by FIAB SPA

08033003264676 - NA2024-03-27 Reusable ECG patient cables
08033695726414 - NA2023-10-17 ECG patient cables USA version
08058480757985 - NA2023-07-28ECG patient cables USA version
08058480757985 - NA2023-07-28 ECG patient cables USA version
38033695726514 - F3001ECG2023-02-24 Disposable solid gel tab electrode for ECG
18058480753984 - SENSITHERM MULTI2022-02-14 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 MULTI2022-02-14 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
08058480754618 - SENSITHERM MULTI2022-02-14 The ST-ADPT-30 adapter cable is an accessory for the SENSITHERM MULTI system that can be inserted in a dedicated socket

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.