Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8022032

FEI Number

3001717360

Entity Name

SOUTHMEDIC, INC.

City/State/Country

BARRIE Ontario, CA

Establishment Address

50 ALLIANCE BLVD.,, BARRIE Ontario L4M 5K3, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SOUTHMEDIC, INC. (Owner Number: 8022032)

Owner / Operator Contact Address

50 ALLIANCE BLVD.,, --, BARRIE, CA-ON L4M 5K3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cannulator ABRA Loop Cannulator Scope Sweeper Dual Action Endoscope Cleaning Brushes Flex Disc, Flex Cup, Flex Reusable Menstrual Disc, Softdisc, Flex Plant+ Menstrual Disc Southmedic Scalpel Handle BetterShield Clear Choice Eye and Face Shields and Frames Capnoxygen Mask Foam Headrest Lancet Southmedic Blades and Scalpels OxyArm OxyMulti Mask OxyMask Ultra OxyTrach Oxy Aerosol Mask OxyMask OxyKid OxyPlus OxyTyke Oxy2Mask Southmedic Surgical Retainer ProCell Surgical Sponge-Blood Recovery Unit Oxy2Mask EtCO2 Oxy2Pro Southmedic Instrument Cleaning Brushes DynaCleft Nasal Elevator DynaCleft Bite Block Multi Dose Inhaler Adapter CRH O'Regan Hemorrhoid Ligator with Integrated Obturator OxyMask Adult Nebulizer Kit OxyPlus Nebulizer Kit ABRA DTS Button Tails ABRA DTS Elastomer Retainer ABRA DTS Silicone Elastomer Cord ABRA Abdominal 3 Row Pack ABRA Abdominal Closure ABRA Surgical Skin Closure ABRA Adhesive Skin Closure

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2014-03-31
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2020-11-03
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2019-07-10
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2025-01-03
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2018-08-28
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2014-04-07
OTV	Research Use Only/Clinical Chemistry Devices	Unknown	Class N	N/A	2012-02-21
OTT	Research Use Only/Microbiology	Unknown	Class N	N/A	2012-02-21
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2019-07-11
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2012-01-17
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2012-05-10
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2008-02-12
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2008-12-22
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	1998-10-15
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-08-15
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2020-06-09
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-11-28
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2025-01-03
MZR	Topical Approximation System	General Hospital	Class 1	880.5240	2014-03-31
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2026-01-07
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2007-12-04
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2011-02-14
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2019-12-06
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-04-12
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2014-03-31
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2017-11-06
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2022-06-29

Official Correspondent

Christine Puddicombe

US Agent Details

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

Related Public Records

Same Entity

SOUTHMEDIC, INC.

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
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26
K881350	Stryker Corp.	CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM	1988-09-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022032. Last updated year: 2026. Please use registration number 8022032 when referencing this establishment in official correspondence.