FDA.reportPublic FDA data

Neonav® ECG Adapter

Primary DI
09369999358679
Brand
Neonav® ECG Adapter
Company
NAVI MEDICAL TECHNOLOGIES PTY LTD
Model
NV1-CN-ADP
Catalog number
NV1-CN-ADP
Published
2025-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
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
19369999358676PackageGS120In Commercial Distribution
09369999358679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1936999935867619369999358676
09369999358679093699993586799369999358679

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead/catheter adaptorA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
744820670
Device count
1
Lot or batch
true
Expiration 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
09369998531356Neonav® ECG Tip Location SystemNV1-SYS-ALLNV1-SYS-ALL2025-08-26
19369999359611Neonav® Adapter CableNV1-CN-ADCNV1-CN-ADC2025-08-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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