Tunneled central lines
Neonav ECG Tip Location System
by Navi Medical Technologies Pty Ltd
An assembly of noninvasive devices intended to use electrocardiographic (ECG) data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC), central venous catheter (CVC), haemodialysis catheter]. It includes a portable battery-powered control unit, ECG cable(s), and ECG lead(s). The catheter (not included) is used as an intravascular electrode, with the guidewire or intraluminal saline used as a conductor. The control unit processes ECG signals and sends them to a separate off-the-shelf device (e.g., smartphone), whereby intravascular ECG changes indicate catheter position typically in conjunction with skin surface ECG data.
Where to buy Neonav ECG Tip Location System
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Neonav ECG Tip Location System models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| NV1-SYS-ALL | — | MR Unsafe | Available |
FDA clearances
- 510(k) K241910 January 2025
Procedures that use tunneled central lines
Frequently asked questions
What is Neonav ECG Tip Location System used for?
An assembly of noninvasive devices intended to use electrocardiographic (ECG) data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC), central venous catheter (CVC), haemodialysis catheter]. It includes a portable battery-powered control unit, ECG cable(s), and ECG lead(s). The catheter (not included) is used as an intravascular electrode, with the guidewire or intraluminal saline used as a conductor. The control unit processes ECG signals and sends them to a separate off-the-shelf device (e.g., smartphone), whereby intravascular ECG changes indicate catheter position typically in conjunction with skin surface ECG data.
Who makes Neonav ECG Tip Location System?
Neonav ECG Tip Location System is made by Navi Medical Technologies Pty Ltd. It is listed under tunneled central venous catheters (broviac, hickman) in our device library.
What sizes does Neonav ECG Tip Location System come in?
The FDA device database does not list sizes for Neonav ECG Tip Location System. Check the instructions for use or ask a Navi Medical Technologies Pty Ltd representative.
Is Neonav ECG Tip Location System MRI safe?
The FDA device database lists Neonav ECG Tip Location System as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is Neonav ECG Tip Location System FDA cleared?
Neonav ECG Tip Location System is covered by FDA submission K241910.
How do I contact a Navi Medical Technologies Pty Ltd sales representative?
Navi Medical Technologies Pty Ltd has not listed representatives on LA Vascular yet. Visit the Navi Medical Technologies Pty Ltd company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.