Landmark Catheter Introducer Kit LR-KIT

GUDID B090LRKIT1

The Landmark Catheter Introducer Kit is intended to aid in gaining vascular access, placement, and securing the Landmark REBOA Catheter to the patient. The suture in this kit is intended for temporary securement of the catheter clamp to the patient’s skin. The suture and clamp are to be removed immediately after the catheter is withdrawn.

ZIEN MEDICAL TECHNOLOGIES, INC.

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable

• Primary Device ID: B090LRKIT1
• NIH Device Record Key: 135cb109-ae77-442c-a926-d824a264ec49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Landmark Catheter Introducer Kit
• Version Model Number: LR-KIT
• Catalog Number: LR-KIT
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B090LRKIT0 [Primary]
HIBCC	B090LRKIT1 [Package]; Contains: B090LRKIT0; Package: Shipper [5 Units]; In Commercial Distribution

FDA Product Code

• OFC: Catheter Introducer Kit

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: 2024-05-02
• Device Publish Date: 2024-04-24

Devices Manufactured by ZIEN MEDICAL TECHNOLOGIES, INC.

• 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
• B090LRKIT1 - Landmark Catheter Introducer Kit: 2024-05-02The Landmark Catheter Introducer Kit is intended to aid in gaining vascular access, placement, and securing the Landmark REBOA Catheter to the patient. The suture in this kit is intended for temporary securement of the catheter clamp to the patient’s skin. The suture and clamp are to be removed immediately after the catheter is withdrawn.
• B090LRKIT1 - Landmark Catheter Introducer Kit: 2024-05-02 The Landmark Catheter Introducer Kit is intended to aid in gaining vascular access, placement, and securing the Landmark REBOA C
• B090LRN0591 - LANDMARK: 2024-01-31 The LANDMARK REBOA catheter is intended for temporary occlusion of large vessels including patients requiring emergency control
• B090ASP10131 - Control 7F Mechanical Thrombectomy System: 2023-05-11 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft em
• B090ASP10211 - Control 11F Mechanical Thrombectomy System: 2023-05-11 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft em