F9007

GUDID 08033695721723

Rubber balls for FIAB suction chest electrodes, Ø 33mm dimensions. F9007 model is used as a replacement of old rubber balls. They are made of blue PVC. LATEX free. FIAB compatible ref models F9003 – F9009 – F9016

FIAB SPA

Electrocardiographic electrode, reusable
Primary Device ID08033695721723
NIH Device Record Key4b45b0ad-7e5a-46e0-baff-5136fbc588d4
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberF9007
Catalog NumberF9007
Company DUNS439770017
Company NameFIAB SPA
Device Count6
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS108033695721723 [Primary]
GS178033695721722 [Unit of Use]

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-08-31
Device Publish Date2020-06-13

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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)
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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
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