AccessGUDID - DEVICE: LANDMARK (B090LRN0590)

GUDID

Device Identifier (DI) Information

Brand Name: LANDMARK
Version or Model: LR-N-059
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LR-N-059
Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.

Primary DI Number: B090LRN0590
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017535668 *Terms of Use

Device Description: The LANDMARK REBOA catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

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
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
Catheter Working Length: 59 Centimeter
Introducer Sheath Compatibility: 7 French

Device Record Status

Public Device Record Key: e021279a-370c-42d1-b2a1-9ed46d3e57be
Public Version Date: January 31, 2024
Public Version Number: 1
DI Record Publish Date: January 23, 2024