Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011854984

FEI Number

3011854984

Entity Name

L-D TOOL & DIE DIVISION OF MADIX ENGINEERING

City/State/Country

Ottawa Ontario, CA

Establishment Address

139 Iber Road, Ottawa Ontario K2S 1E7, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

L-D Tool & Die Division of Madix Engineering (Owner Number: 10057048)

Owner / Operator Contact Address

139 Iber Road, Ottawa, CA-ON K2S 1E7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Colli-Pee® UCM® FV-5020 Urine Collection Container Colli-Pee® FV-5004 Urine Collection Container Colli-Pee First Void Urine Collection Container Colli-Pee® FV-5020c Urine Collection Container Colli-Pee® Small Volumes Colli-Pee® UCM® FV-5010 Urine Collection Container Colli-Pee® UCM® FV-5003b Urine Collection Container Colli-Pee® FV-5010 Urine Collection Container Colli-Pee® UAS® FV-5040 Urine Collection Container Colli-Pee® FV-5040 Urine Collection Container Colli-Pee® FV-5020 Urine Collection Container Swiftsure SwishKit Support Breathing Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2018-02-14
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2024-02-13
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-04-26
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2021-06-10

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

L-D Tool & Die Division of Madix Engineering

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011854984. Last updated year: 2026. Please use registration number 3011854984 when referencing this establishment in official correspondence.