ESOTEST MULTI PATIENT CABLE

Primary DI
08054953344010
Brand
ESOTEST MULTI PATIENT CABLE
Company
FIAB SPA
Model
F5417/US
Catalog number
F5417/US
Device description
The patient cable, F5417/US is the component of ESOTEST MULTI which connects the main unit to the disposable temperature probe ESOTEST MULTI Probe. The F5417/US is supplied with the 30115 ESOTEST MULTI MONITOR. The handle at one end of the cable contains both the electronic circuits which digitize the temperatures and the components that make ESOTEST MULTI immune to the effects of a defibrillator discharge and other EMC disturbances. An 18 contact custom socket on one side of the handle allows the user to connect the ESOTEST MULTI to a mapping system using the ESOTEST MULTI Adapter Cable. The F5417/US is supplied with the ESOTEST MULTI MONITOR 30115.The ESOTEST MULTI Patient Cable (F5417/US model number) is supplied togheter with the ESOTEST MULTI MONITOR (30115 model number) for the use of the ESOTEST Multi probe ( 2617376H/US and 2615358H/US model numbers).
Published
2019-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192210000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192210000ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa2019-10-10FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054953344010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054953344010080549533440108054953344010

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal temperature monitorAn electronic device used to monitor the temperature of the oesophagus during surgical ablation of the wall of the left atrium. It typically measures the oesophageal temperature at several adjacent levels, and displays these temperature values simultaneously to help the surgeon avoid the application of heat high enough to form atrial-oesophageal fistulas. A dedicated probe is inserted into the oesophagus and is connected to the monitor. An acoustic alarm may be included to indicate oesophageal temperatures have exceeded pre-set limits.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
439770017
Device count
1
Lot or batch
true

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18033695727142NAF7244F72442020-05-14
18033695727159NAF7255F72552020-05-14
18033695727166NAF7277F72772020-05-14
18033695727456NAF7244/1F7244/12020-05-14
08033695726414NAF6748RAHAF6748RAHA2023-10-09

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