TwinFlo™ Catheter - The TwinFlo™ Catheter consists of a two - Thermopeutix, Inc.

Duns Number:138648154

Device Description: The TwinFlo™ Catheter consists of a two concentric tubular shafts (inflow and outflow lume 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.

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More Product Details

Catalog Number

-

Brand Name

TwinFlo™ Catheter

Version/Model Number

DF80-115/80

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MJN

Product Code Name

Catheter, Intravascular Occluding, Temporary

Device Record Status

Public Device Record Key

bc5e43d2-42fc-4993-b86f-33a0fd17dc25

Public Version Date

March 21, 2019

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THERMOPEUTIX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 65