LANDMARK LR-N-059

GUDID B090LRN0591

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

ZIEN MEDICAL TECHNOLOGIES, INC.

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: B090LRN0591
• NIH Device Record Key: e021279a-370c-42d1-b2a1-9ed46d3e57be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LANDMARK
• Version Model Number: LR-N-059
• Catalog Number: LR-N-059
• Company DUNS: 017535668
• Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B090LRN0590 [Primary]
HIBCC	B090LRN0591 [Package]; Contains: B090LRN0590; Package: Shelf Carton [1 Units]; In Commercial Distribution
HIBCC	B090LRN0592 [Package]; Package: Shipper [5 Units]; In Commercial Distribution

FDA Product Code

• MJN: Catheter, Intravascular Occluding, Temporary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-31
• Device Publish Date: 2024-01-23

Devices Manufactured by ZIEN MEDICAL TECHNOLOGIES, INC.

• 00860412001572 - SAM Medical: 2024-11-18 Repositionable Chest Tube (RCT) catheters intended for use in pleural fluid drainage.
• 00850068519057 - SAM Medical: 2024-11-08 The SAM IO Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proxima
• 00850068519088 - SAM Medical: 2024-11-08 The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (prox
• 00850068519118 - SAM Medical: 2024-11-08 The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (prox
• B0902P0130B1 - Knight Microcatheter: 2024-05-08 The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective inf
• B0902P0130S1 - Knight Microcatheter: 2024-05-08 The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective inf
• B090E20130B1 - XO Cath: 2024-05-08 The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective in
• B090E20130S1 - XO Cath: 2024-05-08 The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective in