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GORE® Tri Lumen Catheter

FDA UDI

Class II (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE® Tri Lumen Catheter FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
140CM TRI-LUMEN CATHETER FDA UDI
Model / Reference
TLC140 FDA UDI
Description
140CM TRI-LUMEN CATHETER FDA UDI

Identifiers

Catalog Number
TLC140 FDA UDI
Primary DI / UDI-DI
00733132644421 FDA UDI
510(k) Number
K180919 FDA UDI
FDA Product Code
DQY FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 12 French FDA UDI
Catheter Working Length — 140 Centimeter FDA UDI
Length — 1400 Millimeter FDA UDI

Category: Vascular guide-catheter, single-use

GORE® Tri Lumen Catheter by W. L. Gore & Associates, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guide-catheter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (1)

  • FDA UDI a13d0323-2920-4acc-9b4e-9e4221f7b1ba 37 fields · synced Jun 8, 2026