TwinFlo™ Catheter

Primary DI
M781DF10135901
Brand
TwinFlo™ Catheter
Company
Thermopeutix, Inc.
Model
DF10-135/90
Device description
The TwinFlo™ Catheter consists of a two concentric tubular shafts (inflow and outflow lumens, IFL and OFL) that can infuse diagnostic and therapeutic agents to selected regions, as well as direct arterial blood or other solutions to a specific region or organ. The lumens may be accessed using external devices connected to these lumens. There are two additional smaller lumens; one lumen is used for inflation of the distal balloon on the inflow lumen while the second small lumen permits pressure monitoring distal to the balloon. Inflation of the balloon isolates the region distal to the balloon permitting infusion into the vascular region of interest. When used to provide perfusion or control blood flow, blood exits via the outflow lumen to an extracorporeal circuit and is returned via the inflow lumen distal to the inflated balloon. The catheter is supplied with hydrophilic coating.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJNCatheter, Intravascular Occluding, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M781DF10135901PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-29 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-858-549-1760customer.service@thermopeutix.com

Regulatory Flags#

DUNS number
138648154
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M78110010101TAPAS® Catheter100-10102016-09-19
M78110045251TAPAS® Catheter100-45252016-09-19
M78110060601TAPAS® Catheter100-60602016-09-19
M78110080801TAPAS® Catheter100-80802016-09-19
M78110445451TAPAS® Catheter 104-45452016-09-15
M78110460601TAPAS® Catheter 104-60602016-09-15
M78110480801TAPAS® Catheter 104-80802016-09-15
M7819110451TAPAS® Catheter91-10452016-09-19
M7819110601TAPAS® Catheter91-10602016-09-19
M7819110801TAPAS® Catheter91-10802016-09-19
M7819145251TAPAS® Catheter91-45252016-09-19
M7819145451TAPAS® Catheter91-45452016-09-19
M7819160251TAPAS® Catheter91-60252016-09-19
M7819160451TAPAS® Catheter91-60452016-09-19
M7819160601TAPAS® Catheter91-60602016-09-19
M7819180251TAPAS® Catheter91-80252016-09-19
M7819180451TAPAS® Catheter91-80452016-09-19
M7819180601TAPAS® Catheter91-80602016-09-19
M7819180801TAPAS® Catheter91-80802016-09-19
M7819210101TAPAS® Catheter92-10102016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810060550816Bridge Plus occlusion balloonPhilips Image Guided Therapy CorporationMJN2025-10-09
00850001105118Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.MJN2025-06-20
00842429117545SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117552SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117569SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117583SCEPTERMicrovention, Inc.MJN2025-04-30
00842429106884Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106891Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106907Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106945Balloon CatheterMicrovention, Inc.MJN2025-04-22
10628678061054COBRA-OS®Front Line Medical Technologies Inc.MJN2024-03-22
10628678061061Syringe, 10 mLFront Line Medical Technologies Inc.MJN2024-03-22
B090LRN0590LANDMARKZIEN MEDICAL TECHNOLOGIES, INC.MJN2024-01-23
B090LRN0591LANDMARKZIEN MEDICAL TECHNOLOGIES, INC.MJN2024-01-23
10628678061009COBRA-OS™Front Line Medical Technologies Inc.MJN2023-08-25
10628678061016COBRA-OS™Front Line Medical Technologies Inc.MJN2023-08-25
10628678061023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2023-08-25
20763000293424Cadence ™ Precision Injector Thread 1 mL SyringeMicro Therapeutics, Inc.MJN2022-12-23
00850001105057Prytime Medical Devices Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00850001105064Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00842429103388Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103395Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103401Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103418Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429106563Balloon CatheterMicrovention, Inc.MJN2022-06-14
00853359008414SniperEmbolx, Inc.MJN2022-05-18
16286780610016COBRA-OS™Front Line Medical Technologies Inc.MJN2022-02-09
16286780610023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2022-02-09
16286780610009COBRA-OS™Front Line Medical Technologies Inc.MJN2022-01-28
00853892004447Terumo Aortic BalloonQXMEDICALMJN2021-09-03