FDA.reportPublic FDA data

ESOTEST INTERCONNECT CABLE

Primary DI
08054242448061
Brand
ESOTEST INTERCONNECT CABLE
Company
FIAB SPA
Model
F5406/ULTRA
Catalog number
F5406/ULTRA
Device description
ESOTEST ULTRA interconnect cable is intended to connect Monitor (ESOTEST ULTRA 30112 model number) to probe (ESOTEST PROBE 26155S/US model number). ESOTEST System is intended for continue esophageal temperature monitoring and it consists of 3 components: monitor, interconnect cable and probe.
Published
2019-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K123361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123361000ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEMFiab Spa2013-02-27FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054242448061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054242448061080542424480618054242448061

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

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

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

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Primary DI, Brand, Company table
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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