FDA Registration
Active
🇺🇸 United States
NT8501908 - Pudenz Three-Way Connector
Reg #: 2023988
·
FEI: 2023988
·
Expires 2025
Products
1
Proprietary Names
83
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Natus Medical Incorporated
- Registration Number
- 2023988
- FEI Number
- 2023988
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6225 Nancy Ridge Dr
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153041
Owner / Operator
- Firm Name
- Natus Medical Incorporated
- Operator Number
- 9004873
- Address
- 3150 Pleasant View Road
- City
- Middleton
- State
- WI
- Postal Code
- 53562
- Country
- US
- Correspondent
- Sanjay Mehta
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2020-03-06 |
Proprietary Names
NT8501908 - Pudenz Three-Way Connector
NT8507210 - Spetzler Lumbar Peritoneal Shunt, One Piece
NT96001S01 - Pudenz Ventricular Catheter
NT8500150 - On-Off Flushing Reservoir
NT8500105 - Multi-Purpose Valve (Low Pressure) with Anti-Siphon Device
NT8500128 - Multi-Purpose Valve (Medium Pressure)
NT98003S01 - Peritoneal Open-Ended Catheter With Slits
NT83026S02 - Mini Natus® CSF Reservoir Side-Inlet
NT8501113 - UltraVS Kit - Standard (Low Pressure)
NT8501215 - Convertible Natus® CSF Reservoir
NT8509011 - NOVUS Valve, Mini (Low Pressure)
NT8501381 - Pudenz Peritoneal Catheter (Medium Pressure)
NT8501357 - Pudenz Flushing Valve (Medium Pressure)
NT8501212 - Side-Inlet Natus® CSF Reservoir
NT8501109 - UltraVS - Standard (Low Pressure)
NT8501110 - UltraVS - Standard (Medium Pressure)
NT8501132 - Large Rickham-Style Reservoir
NT83026S04 - Mini Natus® CSF Reservoir Dual Side-Inlet
NT8501220 - Pudenz Infant Cardiac Catheter (Medium Pessure)
NT8509010 - NOVUS Valve (Low Pressure)
NT8500108 - Multi-Purpose Valve (Medium Pressure) with Anti-Siphon Device
NT8509020 - NOVUS Valve (Medium Pressure)
NT8501900 - Pudenz Nylon Straight Connector
NT83026S03 - Mini Natus® CSF Reservoir Convertible
NT8509610 - Novus Valve Shunt Kit, Standard, Low Pressure
NT8501380 - Pudenz Peritoneal Catheter (Low Pressure)
NT8501114 - UltraVS Kit - Standard (Medium Pressure)
NT8500125 - Multi-Purpose Valve (Low Pressure)
NT8501228 - Pudenz Catheter with Stylet
NT8500155 - On-Off Flushing Reservoir with Anti-Siphon Device
NT8501519 - Pudenz Ventricular Catheter with Stylet
NT8501504 - Pudenz Ventricular Catheter with Stylet
NT8501211 - Standard Natus® CSF Reservoir
NT8501201 - Pudenz Cardiac Catheter (Low Pressure)
NT80076S01 - Edwards-Barbaro Syringo-Peritoneal Shunt
NT8501126 - UltraVS - Neonate (Low Pressure)
NT8501202 - Pudenz Cardiac Catheter (High Pressure)
NT8501200 - Pudenz Cardiac Catheter (Medium Pressure)
NT8509311 - NOVUS Valve, MINI, Shunt Kit, Low Pressure
NT8501124 - UltraVS Kit-Neonate (Medium Pressure)
NT8501376 - Pudenz Open-Ended Catheter With Slits
NT8501123 - UltraVS Kit-Neonate (Low Pressure)
NT8501229 - Portnoy Ventricular Catheter With Stylet
NT8500132 - Multi-Purpose Valve (High Pressure)
NT8500200 - Anti-Siphon Device
NT8501517 - Pudenz Ventricular Catheter with Stylet
NT8501330 - Pudenz Flushing Valve (Low Pressure)
NT8501919 - Double Threaded Nylon Straight Connector
NT8501412 - Pudenz Flushing Valve with Anti-Siphon Device (Medium Pressure)
NT8501410 - Pudenz Flushing Valve with Anti-Siphon Device (Low Pressure)
NT8509620 - Novus Valve, Standard, Shunt Kit Medium Pressure
NT8501221 - Pudenz Infant Cardiac Catheter (Low Pressure)
NT8501390 - Pudenz Peritoneal Catheter Barium Impregnated Stripe (Low Pressure)
NT8501391 - Pudenz Peritoneal Catheter Barium Impregnated Stripe (Medium Pressure)
NT8501121 - Small Rickham-Style Reservoir
NT8501125 - UltraVS Kit-Neonate (High Pressure)
NT8501214 - Side-Inlet Natus® CSF Reservoir
NT99023S01 - Barium Impregnated Ventricular Catheter
NT8501195 - Foltz Flushing Reservoir
NT8509021 - NOVUS Valve, Mini (Medium Pressure)
NT8501359 - Pudenz Flushing Valve (High Pressure)
NT8501411 - Pudenz Flushing Valve with Anti-Siphon Device (Low Pressure)
NT8501128 - UltraVS - Neonate (High Pressure)
NT97001S01 - Luer Connector
NT8501902 - Pudenz Right Angle Connector
NT8501375 - Pudenz Reflux Control Catheter
NT8501413 - Pudenz Flushing Valve with Anti-Siphon Device (Medium Pressure)
NT8501127 - UltraVS - Neonate (Medium Pressure)
NT8501213 - Convertible Natus® CSF Reservoir
NT8501192 - Braden Flushing Reservoir
NT8500112 - Multi-Purpose Valve (High Pressure) with Anti-Siphon Device
NT8501222 - Pudenz Infant Cardiac Catheter (High Pressure)
NT8501356 - Pudenz Flushing Valve (Medium Pressure)
NT8501911 - Threaded Nylon Straight Connector
NT8501515 - Pudenz Ventricular Catheter with Stylet
NT83026S01 - Mini Natus® CSF Reservoir Standard
NT8501382 - Pudenz Peritoneal Catheter (High Pressure)
NT8501210 - Standard Natus® CSF Reservoir
NT8501414 - Pudenz Flushing Valve with Anti-Siphon Device (High Pressure)
NT8501358 - Pudenz Flushing Valve (High Pressure)
NT8501331 - Pudenz Flushing Valve (Low Pressure)
NT8509321 - NOVUS Valve, MINI, Shunt Kit, Medium Pressure
NT97105S01 - Spetzler Lumbar Peritoneal Shunt System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198