GORE® Tri Lumen Catheter TLC140

GUDID 00733132644421

140CM TRI-LUMEN CATHETER

W. L. Gore & Associates, 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 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 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: 00733132644421
• NIH Device Record Key: a13d0323-2920-4acc-9b4e-9e4221f7b1ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE® Tri Lumen Catheter
• Version Model Number: TLC140
• Catalog Number: TLC140
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter
• Catheter Gauge: 12 French
• Catheter Working Length: 140 Centimeter
• Length: 1400 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132644421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180919

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: 2024-03-08
• Device Publish Date: 2024-02-29

Devices Manufactured by W. L. Gore & Associates, Inc.

• 00733132644421 - GORE® Tri Lumen Catheter: 2024-03-08140CM TRI-LUMEN CATHETER
• 00733132644421 - GORE® Tri Lumen Catheter: 2024-03-08 140CM TRI-LUMEN CATHETER
• 00733132658251 - GORE VIABAHN VBX Balloon Expandable Endo: 2023-12-19 BX2 HEP REDUCED PROFILE BX2 5MMX15MM 6Fr 80CM Cath
• 00733132658268 - GORE VIABAHN VBX Balloon Expandable Endo: 2023-12-19 BX2 HEP REDUCED PROFILE BX2 5MMX15MM 6Fr 135CM Cath
• 00733132658275 - GORE VIABAHN VBX Balloon Expandable Endo: 2023-12-19 BX2 HEP REDUCED PROFILE BX2 5MMX19MM 6Fr 80CM Cath
• 00733132658282 - GORE VIABAHN VBX Balloon Expandable Endo: 2023-12-19 BX2 HEP REDUCED PROFILE BX2 5MMX19MM 6Fr 135CM Cath
• 00733132658299 - GORE VIABAHN VBX Balloon Expandable Endo: 2023-12-19 BX2 HEP REDUCED PROFILE BX2 5MMX29MM 6Fr 80CM Cath
• 00733132658305 - GORE VIABAHN VBX Balloon Expandable Endo: 2023-12-19 BX2 HEP REDUCED PROFILE BX2 5MMX29MM 6Fr 135CM Cath
• 00733132658312 - GORE VIABAHN VBX Balloon Expandable Endo: 2023-12-19 BX2 HEP REDUCED PROFILE BX2 5MMX39MM 6Fr 80CM Cath