FDA.reportPublic FDA data

FM-HUB

Primary DI
00845225012496
Brand
FM-HUB
Company
VOLCANO CORPORATION
Model
409-0100.01
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DSKComputer, Blood-Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSKComputer, Blood-PressureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152582000CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxVolcano Corporation2015-12-03DSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225012496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225012496008452250124968452250124960845225012496

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular haemodynamic monitoring systemAn assembly of devices used for the continuous in vivo measurement and display of blood pressure and blood flow velocity in all blood vessels, including the coronary and peripheral arteries, during diagnostic and/or interventional procedures. It typically includes a vascular pressure/flow measuring guidewire equipped with transducers/sensors at its working end, a computer with a touchscreen monitor to display the readings, and alarms; it may also include an electrocardiograph (ECG) input, a printer, and a remote control. The system is used to obtain haemodynamic information for the diagnosis and treatment of blood vessel disease.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
135179237
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845225012663CORE M2 Vascular System400-0100.17400-0100.172017-06-06
00845225012731SmartMap Pressure System800573001-ROHS800573001-ROHS2016-09-19
00184360000327R-1008045470018045470012016-09-12
00845225010874ComboMap Pressure and Flow System 68008027450012016-12-08
20845225012681SpinVision STERILE EQUIPEMENT COVER891BG2016-09-08
20845225012698DIGITAL IVUS STERILE EQUIPEMENT COVER5902VC2017-03-02
00845225002527Crux® Vena Cava FIlter, Femoral70242015-09-17
00845225002534Crux® Vena Cava FIlter, Jugular70252015-09-17
00845225010195S5 IMAGING SYSTEM P/N 8073000018073000012016-09-22
00845225010218s5i Imaging System8074000012016-09-12
00845225012472CORE FM SYSTEM400-0100.112016-09-12
00845225012670CORE Series Precision Guided Therapy SystemS18081AA2016-09-12
00184360000167FloWire Doppler Guide Wire XT 175cm 014 JTIP1403J2016-08-24
00184360000198FloWire Doppler Guide Wire XT 300cm 014 ST14132016-08-24
00184360000204FloWire Doppler Guide Wire XT 300cm 014 JTIP1413J2016-08-24
00184360000334ComboWire Pressure/Flow Guide Wrie XT 1.5cm Sensor95152016-08-24
00184360000341ComboWire Pressure/Flow Guide Wire XT95002016-08-24
00184360000686s5i Imaging System Workstation 8074010012016-09-12
00845225012656CORE FM CART410-0100.112016-09-12
00845225001261LoMap8094850012016-09-12

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Primary DI, Brand, Company table
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