AccessGUDID - DEVICE: TwinFlo™ Catheter (M781DF10135901)

GUDID

Device Identifier (DI) Information

Brand Name: TwinFlo™ Catheter
Version or Model: DF10-135/90
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Thermopeutix, Inc.

Primary DI Number: M781DF10135901
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 138648154 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32584	Intravascular occluding balloon catheter, image-guided	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MJN	Catheter, Intravascular Occluding, Temporary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -29 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Sheath Compatibility: 14 Fr
Device Size Text, specify: Outflow Length: 90 cm
Device Size Text, specify: Inflow Length: 135 cm
Device Size Text, specify: Balloon Diameter: 10.0 mm

Device Record Status

Public Device Record Key: ef8f4345-0c41-43a5-b4db-f30878854c55
Public Version Date: December 04, 2023
Public Version Number: 4
DI Record Publish Date: September 19, 2016