AccessGUDID - DEVICE: Venture® 038 catheter (M20658230)

GUDID

Device Identifier (DI) Information

Brand Name: Venture® 038 catheter
Version or Model: 5823
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20658230
Issuing Agency: HIBCC
Commercial Distribution End Date: November 08, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 008999906 *Terms of Use

Device Description: The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.

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?
32151	Peripheral vascular intervention infusion catheter	A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	Catheter, Percutaneous

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 120 Centimeter

Device Record Status

Public Device Record Key: fd3f53db-23af-40f2-bf08-591459220b29
Public Version Date: June 10, 2022
Public Version Number: 8
DI Record Publish Date: January 08, 2018