XO Cross 14 C14-135

GUDID B090C141351

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

ZIEN MEDICAL TECHNOLOGIES, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: B090C141351
• NIH Device Record Key: 28a0ddc6-4291-4b2b-91b7-7b7ffebbe7da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XO Cross 14
• Version Model Number: C14-135
• Catalog Number: C14-135
• 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: false
• 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 Gauge: 2 French
• Catheter Working Length: 135 Centimeter
• Crossing Profile: 1.6 French
• Introducer Sheath Compatibilit: 2.9 French
• Catheter Gauge: 2 French
• Catheter Working Length: 135 Centimeter
• Crossing Profile: 1.6 French
• Introducer Sheath Compatibilit: 2.9 French
• Catheter Gauge: 2 French
• Catheter Working Length: 135 Centimeter
• Crossing Profile: 1.6 French
• Introducer Sheath Compatibilit: 2.9 French
• Catheter Gauge: 2 French
• Catheter Working Length: 135 Centimeter
• Crossing Profile: 1.6 French
• Introducer Sheath Compatibilit: 2.9 French
• Catheter Gauge: 2 French
• Catheter Working Length: 135 Centimeter
• Crossing Profile: 1.6 French
• Introducer Sheath Compatibilit: 2.9 French
• Catheter Gauge: 2 French
• Catheter Working Length: 135 Centimeter
• Crossing Profile: 1.6 French
• Introducer Sheath Compatibilit: 2.9 French
• Catheter Gauge: 2 French
• Catheter Working Length: 135 Centimeter
• Crossing Profile: 1.6 French
• Introducer Sheath Compatibilit: 2.9 French
• Catheter Gauge: 2 French
• Catheter Working Length: 135 Centimeter
• Crossing Profile: 1.6 French
• Introducer Sheath Compatibilit: 2.9 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B090C141350 [Primary]
HIBCC	B090C141351 [Package]; Contains: B090C141350; Package: Shelf Carton [1 Units]; In Commercial Distribution
HIBCC	B090C141352 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2022-06-28
• Device Publish Date: 2022-06-20

On-Brand Devices [XO Cross 14]

• B090C141751: The XO Cross device is a support catheter intended to guide and support a guidewire during acces
• B090C14135H1: The XO Cross device is a support catheter intended to guide and support a guidewire during acces
• B090C141351: The XO Cross device is a support catheter intended to guide and support a guidewire during acces
• B090C140901: The XO Cross device is a support catheter intended to guide and support a guidewire during acces
• B090C14175H1: The XO Cross device is a support catheter intended to guide and support a guidewire during acces
• B090C14090H1: The XO Cross device is a support catheter intended to guide and support a guidewire during acces