FDA UDI
In Commercial Distribution
🇺🇸 United States
Neonav® Adapter Cable
DI: 09369999359614
·
Model: NV1-CN-ADC
·
NAVI MEDICAL TECHNOLOGIES PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Neonav® Adapter Cable
- Primary DI
- 09369999359614
- Version / Model
- NV1-CN-ADC
- Catalog Number
- NV1-CN-ADC
- 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
- c4576d83-546f-4c4f-bb0d-fc7ec8b32fef
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| 61564 | Central venous catheter navigation system, electrocardiographic | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 19369999359611 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 09369999359614 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241910 | 000 |