Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611004

FEI Number

3002807099

Entity Name

GO MEDICAL INDUSTRIES PTY. LTD.

City/State/Country

SUBIACO Western Australia, AU

Establishment Address

200 Churchill Avenue, SUBIACO Western Australia 6008, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GO MEDICAL INDUSTRIES PTY. LTD. (Owner Number: 8020024)

Owner / Operator Contact Address

200 Churchill Ave, SUBIACO, AU-WA 6008, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K890400

PMA Number

N/A

All Registered Proprietary Names

O'Neil Sterile Field Urinary Catheter V-Sets O'Neil Nasal Spray Amnicot Catherter, Urological

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2008-02-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-04
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2011-09-12
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	2008-02-04
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2008-02-04

Official Correspondent

No official correspondent registered.

US Agent Details

Amanda SINGLETON Business: Compliance Systems International LLC Email: amanda.compliance.sys.intl@gmail.com Phone: (716) 4407364

Related Public Records

Same Entity

GO MEDICAL INDUSTRIES PTY. LTD.

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
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
9613662	MEDISCAN GMBH & CO. KG	KREMSMUNSTER Oberosterreich, AT
3008502431	HR PHARMACEUTICALS, INC d/b/a HR HealthCare	York, PA, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
3006606901	COLOPLAST HUNGARY KFT	NYIRBATOR Szabolcs-Szatmar-Bereg, HU
3008806809	ConvaTec Limited, GDC Building	Deeside Flintshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611004. Last updated year: 2026. Please use registration number 9611004 when referencing this establishment in official correspondence.