Goodale-Lubin™

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: Goodale-Lubin™ FDA UDI
Generic Name: Angiographic catheter, single-use FDA UDI
Device Name: WVN CATH 001279 10PK 5420 5 80 GOODLUBN FDA UDI
Model / Reference: 001279 FDA UDI
Description: WVN CATH 001279 10PK 5420 5 80 GOODLUBN FDA UDI

Identifiers

Primary DI / UDI-DI: 00613994964595 FDA UDI
FDA Product Code: DQO FDA UDI
GMDN Term: Angiographic catheter, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 5.0 French FDA UDI
Length — 80.0 Centimeter FDA UDI
Lumen/Inner Diameter — 0.889 Millimeter FDA UDI

Category: Angiographic catheter, single-use

Goodale-Lubin™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Angiographic catheter, single-use.

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ConcierGE Guiding Excellence™ — Merit Medical Systems, Inc. · Class II
INFINITI — Cordis US Corp. · Class II
CXI — COOK INCORPORATED · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtronic, Inc.

Sources (1)

FDA UDI bad8eabc-2106-47cb-b481-fe9c8acd378c 36 fields · synced May 29, 2026