AccessGUDID - DEVICE: Paxwire Occlusion Balloon System (M465ACX10106)

GUDID

Device Identifier (DI) Information

Brand Name: Paxwire Occlusion Balloon System
Version or Model: ACX101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ACX101
Company Name: Access Closure, Inc.

Primary DI Number: M465ACX10106
Issuing Agency: HIBCC
Commercial Distribution End Date: October 16, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 132286761 *Terms of Use

Device Description: The PaxWire Balloon Occlusion System is indicated for temporary flow occlusion in the iliofemoral artery.

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":	Yes
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Maximum balloon diameter 12mm
Device Size Text, specify: Effective length 99cm

Device Record Status

Public Device Record Key: 61062555-0d84-47fa-be89-953c527b60af
Public Version Date: October 17, 2024
Public Version Number: 7
DI Record Publish Date: May 09, 2016