Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030148766

FEI Number

3030148766

Entity Name

NAVI MEDICAL TECHNOLOGIES PTY LTD

City/State/Country

Carlton Victoria, AU

Establishment Address

L 2 700 Swanston Street, Carlton Victoria 3053, AU

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Navi Medical Technologies Pty Ltd (Owner Number: 10093411)

Owner / Operator Contact Address

Melbourne Connect, Level 2, 700 Swanston Street, Carlton, AU-VIC 3053, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241910

PMA Number

N/A

All Registered Proprietary Names

Neonav ECG Tip Location System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-05-12

Official Correspondent

Mubin Yousuf

US Agent Details

Shing Yue Sheung Email: shing.sheung@navitechnologies.com Phone: (800) 9288806

Related Public Records

Same Entity

Navi Medical Technologies 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
K971999	B.Braun Medical, Inc.	PERIPHERALLY INSERTED CENTRAL	1997-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Z-0004-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0025-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
Z-0026-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.
Z-0027-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

Similar Registrations

Registration Number	Establishment Name	Location
1018233	C.R. BARD, INC.	COVINGTON, GA, US
1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US
1000314502	ADVANTECH CORPORATION	Milpitas, CA, US
9612433	VYGON Germany GmbH	AACHEN North Rhine-Westphalia, DE
3030714660	SPECTRUM VASCULAR	White Plains, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030148766. Last updated year: 2026. Please use registration number 3030148766 when referencing this establishment in official correspondence.