Neonav® ECG Adapter NV1-CN-ADP

GUDID 09369999358679

NAVI MEDICAL TECHNOLOGIES PTY LTD

Electrocardiographic lead/catheter adaptor

• Primary Device ID: 09369999358679
• NIH Device Record Key: 94919775-6f77-4c02-9e40-908cfbaab541
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neonav® ECG Adapter
• Version Model Number: NV1-CN-ADP
• Catalog Number: NV1-CN-ADP
• Company DUNS: 744820670
• Company Name: NAVI MEDICAL TECHNOLOGIES PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09369999358679 [Primary]
GS1	19369999358676 [Package]; Package: Box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241910

FDA Product Code

• LJS: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-03
• Device Publish Date: 2025-08-26

Devices Manufactured by NAVI MEDICAL TECHNOLOGIES PTY LTD

• 19369900073438 - Neonav® Clip Cable: 2025-09-03
• 09369998531356 - Neonav® ECG Tip Location System: 2025-09-03
• 09369999358679 - Neonav® ECG Adapter: 2025-09-03
• 09369999358679 - Neonav® ECG Adapter: 2025-09-03
• 19369999359611 - Neonav® Adapter Cable: 2025-09-03