Neonav® ECG Adapter

Basic Information

• Brand Name: Neonav® ECG Adapter
• Primary DI: 09369999358679
• Version / Model: NV1-CN-ADP
• Catalog Number: NV1-CN-ADP
• Company Name: NAVI MEDICAL TECHNOLOGIES PTY LTD
• Labeler DUNS: 744820670
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-26
• Public Version: 1
• Public Version Date: 2025-09-03
• Public Version Status: New
• Public Device Record Key: 94919775-6f77-4c02-9e40-908cfbaab541

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	880.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47483	Electrocardiographic lead/catheter adaptor	A small, sterile, connecting device that enables a mechanical union between an in situ cardiac catheter [e.g., an electrophysiology (EP) diagnostic catheter] and an electrocardiograph (ECG) cable/lead for transmission of heart signals to an ECG machine. This device allows the connection of the otherwise incompatible connectors of the cardiac catheter to a standard ECG cable/lead or a cable/lead of different manufacture. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09369999358679	GS1
Package	19369999358676	GS1	Box	20	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K241910	000