FDA.reportPublic FDA data

Neonav® ECG Tip Location System

Primary DI
09369998531356
Brand
Neonav® ECG Tip Location System
Company
NAVI MEDICAL TECHNOLOGIES PTY LTD
Model
NV1-SYS-ALL
Catalog number
NV1-SYS-ALL
Published
2025-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241910000Neonav ECG Tip Location SystemNavi Medical Technologies2025-01-19LJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09369998531356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09369998531356093699985313569369998531356

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheter navigation system, electrocardiographicAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
744820670
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09369900073431Neonav® Clip CableNV1-CN-CLINV1-CN-CLI2025-08-26
09369999359614Neonav® Adapter CableNV1-CN-ADCNV1-CN-ADC2025-08-26
19369900073438Neonav® Clip CableNV1-CN-CLINV1-CN-CLI2025-08-26
09369999358679Neonav® ECG AdapterNV1-CN-ADPNV1-CN-ADP2025-08-26
19369999359611Neonav® Adapter CableNV1-CN-ADCNV1-CN-ADC2025-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741240034PowerPICC SOLOBard Access Systems, Inc.LJS2026-05-27
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00801741240058PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
H787MRC3S9110AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
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H787MRC3S9160C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
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H787MRC3S960C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
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H96560M0411550BioFloNAVILYST MEDICAL, INC.LJS2021-05-14
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H954PKM033511S0BioFloNAVILYST MEDICAL, INC.LJS2021-03-08