Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020315

FEI Number

5804

Entity Name

PRETIUM CANADA PACKAGING ULC

City/State/Country

ETOBICOKE Ontario, CA

Establishment Address

50-A STEINWAY BLVD., ETOBICOKE Ontario M9W 6Y3, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PRETIUM CANADA PACKAGING ULC (Owner Number: 8020315)

Owner / Operator Contact Address

50-A STEINWAY BLVD., --, ETOBICOKE, CA-ON M9W 6Y3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K944847

PMA Number

N/A

All Registered Proprietary Names

Leakbuster Leakbuster Space Saver Urine Culture and Urinalysis Preservative Tube (V102-CA) Spout Cap Quick Turn Starswab II Bacteriology Culture Collection and Transport System Quick Turn Pinworm Collector (V302-PIN) Leakbuster Starswab Anaerobic Transport System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	1980-07-28
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2018-08-03
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2014-12-10
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2007-12-07
JSL	Culture Media, Anaerobic Transport	Microbiology	Class 1	866.2390	2007-12-07

Official Correspondent

TIFFANY DAVIS

US Agent Details

Lisa Clayton Business: Starplex Scientific Corp Email: lclayton@starplexusa.com Phone: (423) 5996059

Related Public Records

Same Entity

PRETIUM CANADA PACKAGING ULC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18

Similar Registrations

Registration Number	Establishment Name	Location
3006847360	Corning Science Mexico	Reynosa Tamaulipas, MX
3010610454	JinJiang Honghai Plastics Industrial Co., Ltd.	Jinjiang, Fujian, CN
3027655366	SEAIN SOLUTION LTD.	Taipei, TW
3015173212	Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, MX
3038613790	JIE GAO MEDICAL PLASTIC PRODUCTS (MALAYSIA) SDN. BHD.	Klang Selangor, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020315. Last updated year: 2026. Please use registration number 8020315 when referencing this establishment in official correspondence.