FDA Registration
Active
🇺🇸 United States
Natus Medical Incorporated
Reg #: 2023988
·
FEI: 2023988
·
Expires 2026
Products
7
Proprietary Names
246
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- Natus Medical Incorporated
- Registration Number
- 2023988
- FEI Number
- 2023988
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6225 Nancy Ridge Dr
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K954021
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 | 2019-10-03 |
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | Class 2 | Neurology | No | 2018-10-15 |
| Instrument, Shunt System Implantation | GYK | Class 1 | Neurology | No | 2020-03-06 |
| Port & Catheter, Implanted, Subcutaneous, Intraventricular | LKG | Class 2 | Neurology | No | 2019-12-12 |
| Intracranial Pressure & Temperature Monitoring Kit | PSP | Class 2 | Neurology | No | 2019-02-12 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2018-01-26 |
| Stainless Steel Instrument, Shunt System Implantation | PIY | Class 1 | Neurology | No | 2019-12-12 |
Proprietary Names
External Drain System II
External Drain System II Bag with tubing
NT821738C, Lumbar Catheter Kit II with EDS 3 CSF External Drainage System
NT821731C, EDS 3 CSF External Drainage System
NT821730C, EDS 3 CSF External Drainage System With Ventricular Catheter
NT951101A - Finned Ventricular Catheter F8, 15 cm
NT9MD102A - Straight Ventricular Catheter F8, 15 cm, With Radiopaque Length Dots
NT161057, Disposable ICP LUER-LOK Connector
NT821733, EDS 3 Leveling Device
NT821732, External Drainage System Collection Bag
NT821739, EVD 1.9mm I.D. Catheter Set
NT821735, EDS 3 Clear Ventricular CSF Catheter
NT999016 - Integral Ventricular Reservoir (Integral Right Angle Ventricular Catheter F8, 4 cm)
NT9MZ500 - Radiopaque Polypropylene Plug
NT999015 - Integral Ventricular Reservoir (Integral Right Angle Ventricular Catheter F8, 3 cm)
NT999110 - BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Polypropylene - 6.4 mm - Depth 2.5 mm)
NT999113 - BURR HOLE RESERVOIR AND SILICONE CAP (Polypropylene - 6.4 mm - Depth 0.8 mm)
NT999111 - BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Polypropylene - 6.4 mm - Depth 0.8 mm)
NT999112 - BURR HOLE RESERVOIR AND SILICONE CAP (Polypropylene - 6.4 mm - Depth 2.5 mm)
Natus Cranial Hand Drill
NT8502002 - Disposable Peritoneal Catheter Passer (36 cm)
NT8502001 - Disposable Peritoneal Catheter Passer (60 cm)
NT821706, Lumbar External Drainage Catheter 46cm With Tuohy Needle
NT821705, External Drainage Ventricular Catheter Set
External Drainage System II Pole Clamp
NT953101 - PERITONEAL CATHETER F7, 91 cm, WITH RADIOPAQUE STRIPE AND 16 SLITS (O.D.: 2.3 mm x I.D.: 1.1 mm)
NT953100 - ATRIAL CATHETER F7, 46 cm, WITH RADIOPAQUE STRIPE (O.D.: 2.3 mm x I.D.: 1.1 mm)
NT9MZ101 - PERITONEAL CATHETER F6, 91 cm, RADIOPAQUE WITH 16 SLITS (O.D.: 2.1 mm x I.D.: 1.1 mm)
NT951102A - Straight Ventricular Catheter F8, 15 cm
NT9MZ100 - ATRIAL CATHETER F6, 46 cm, RADIOPAQUE (O.D.: 2.1 mm x I.D. 1.1 mm)
NT951101 - Finned Ventricular Catheter F8, 15 cm
NT9MZ1011 - PERITONEAL CATHETER F6, 110 cm, RADIOPAQUE WITH 16 SLITS (O.D.: 2.1 mm x I.D.: 1.1 mm)
NT9MD1022 - Straight Ventricular Catheter F8, 25 cm, With Accessories
NT951102 - Straight Ventricular Catheter F8, 15 cm
NT9MD2101 - Subcutaneous Tube Passer
NT999302 - CSF Reservoir Kit (With Right Angle Ventricular Catheter F8, 7 cm)
NT999301 - CSF Reservoir (Volume: 0.6 ml)
NT999304 - CSF Reservoir Kit (With Straight Catheter F8, 15 cm)
NT821707, Lumbar Drainage Catheter Kit II
NT14086 - Contour-Flex Valve System, Small, Medium Pressure At 20 ml/hr: 6.7-11.8 cm H2O
NTCFRL - Contour-Flex Valve Unit, Regular, Low Pressure At 20 ml/hr: 1.2 - 5.8 cm H2O
NTCFSL - Contour-Flex Valve Unit, Small, Low Pressure At 20 ml/hr: 1.2 - 5.8 cm H2O
NTPC1 - Peritoneal Catheter F7, 91 cm, With Radiopaque Stripe and Length Markers
NT11813 - Contour-Flex Valve System, Regular, High Pressure At 20 ml/hr: 12.7-18 cm H2O
NT14085 - Contour-Flex Valve System, Small, Low Pressure At 20 ml/hr: 1.2-5.8 cm H2O
NTCFRM - Contour-Flex Valve Unit, Regular, Medium Pressure At 20 ml/hr: 6.7 - 11.8 cm H2O
NT11811 - Contour-Flex Valve System, Regular, Low Pressure At 20 ml/hr: 1.2-5.8 cm H2O
NT11812 - Contour-Flex Valve System, Regular, Medium Pressure At 20 ml/hr: 6.7-11.8 cm H2O
NT14087 - Contour-Flex Valve System, Small, High Pressure At 20 ml/hr: 12.7-18 cm H2O
NTCFSM - Contour-Flex Valve Unit, Small, Medium Pressure At 20 ml/hr: 6.7 - 11.8 cm H2O
NTCFRH - Contour-Flex Valve Unit, Regular, High Pressure At 20 ml/hr: 12.7 - 18 cm H2O
NTCFSH - Contour-Flex Valve Unit, Small, High Pressure At 20 ml/hr: 12.7 - 18 cm H2O
NTVC1 - Straight Ventricular Catheter F8, 25 cm, With Length Markers
NT9MD102B - STRAIGHT VENTRICULAR CATHETER F8, 15 cm, WITH RADIOPAQUE STRIP & LENGTH MARKERS
NT75121S06 - Lumbar-Peritoneal Shunt Stainless Steel Connector
NT82059S03 - Tuohy Needle
NT83024S01 - Ventricular Catheter Guide
NT9MZ209 - Right Angle Ventricular Catheter F8, 9 cm (Proximal Length: 9 cm - Distal Length: 2 cm)
NT9MZ205 - Right Angle Ventricular Catheter F8, 5 cm (Proximal Length: 5 cm - Distal Length: 2 cm)
NT9MZ203 - Right Angle Ventricular Catheter F8, 3 cm (Proximal Length: 3 cm - Distal Length: 2 cm)
NT9MZ206 - Right Angle Ventricular Catheter F8, 6 cm (Proximal Length: 6 cm - Distal Length: 2 cm)
NT9MZ210 - Right Angle Ventricular Catheter F8, 10 cm (Proximal Length: 10 cm - Distal Length: 2 cm)
NT9MZ211 - Right Angle Ventricular Catheter F8, 11 cm (Proximal Length: 11 cm - Distal Length: 2 cm)
NT9MZ208 - Right Angle Ventricular Catheter F8, 8 cm (Proximal Length: 8 cm - Distal Length: 2 cm)
NT9MZ207 - Right Angle Ventricular Catheter F8, 7 cm (Proximal Length: 7 cm - Distal Length: 2 cm)
NT9MZ204 - Right Angle Ventricular Catheter F8, 4 cm (Proximal Length: 4 cm - Distal Length: 2 cm)
NT991002 - Radiopaque Silicone Right Angle Guides
HITHNDRZR Cranial Access Kit
HITHLTRZR Cranial Access Kit
HITHND Cranial Access Kit
HITH1 Cranial Access Kit
HITHRZR Cranial Access Kit
HITHLT Cranial Access Kit
FLEXEXT Camino Flex Extension Cable
NT9MZ110N - PERITONEAL CATHETER F7, 110 cm, WITH RADIOPAQUE STRIPE WITHOUT SLITS (O.D.: 2.3 mm x I.D. 1.1 mm)
CAM02 Camino ICP Monitor
CAMCABL Camino Fiber Optic Catheter Cable
026950 14.4V Li-ion Battery
025420 PMIO Patient Bedside Monitor Cable
025440 USB-to-RS232 Adapter Cable
025430 AC Power Adapter
NT8507460 - Spetzler Lumbar Peritoneal Flushing Reservoir
NT8507440 - Spetzler Lumbar Peritoneal Flushing Reservoir
NT8507421 - Spetzler In-Line Valve (Medium Pressure)
NT8507420 - Spetzler In-Line Valve (Low Pressure)
NT903320A - H-V LUMBAR VALVE SYSTEM, RED
NT903325A - H-V LUMBAR VALVE SYSTEM, BLUE
NT903330A - H-V LUMBAR VALVE SYSTEM, WHITE
NT903340A - H-V LUMBAR VALVE SYSTEM, BROWN
NT903335A - H-V LUMBAR VALVE SYSTEM, YELLOW
NT903345A - H-V LUMBAR VALVE SYSTEM, GREEN
NT8507422 - Spetzler In-Line Valve (High Pressure)
NT990001 - Malleable Tunnelers 45 cm
NT990010 - Malleable Tunnelers 65 cm
OLM Intracranial Pressure Monitoring Kit, model 110-4B
Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, model 110-4L
Intracranial Pressure/Temperture Monitoring Kit, model 110-4BT
Post Craniotomy Subdural Pressure Monitoring Kit, model 110-4G
NT8509610 - Novus Valve Shunt Kit, Standard, Low Pressure
NT8501222 - Pudenz Infant Cardiac Catheter (High Pressure)
NT8501195 - Foltz Flushing Reservoir
NT8501220 - Pudenz Infant Cardiac Catheter (Medium Pessure)
NT8501200 - Pudenz Cardiac Catheter (Medium Pressure)
NT8501414 - Pudenz Flushing Valve with Anti-Siphon Device (High Pressure)
NT8501358 - Pudenz Flushing Valve (High Pressure)
NT8501212 - Side-Inlet Natus® CSF Reservoir
NT8500112 - Multi-Purpose Valve (High Pressure) with Anti-Siphon Device
NT8501330 - Pudenz Flushing Valve (Low Pressure)
NT8501911 - Threaded Nylon Straight Connector
NT8501382 - Pudenz Peritoneal Catheter (High Pressure)
NT8500128 - Multi-Purpose Valve (Medium Pressure)
NT8501228 - Pudenz Catheter with Stylet
NT8500155 - On-Off Flushing Reservoir with Anti-Siphon Device
NT8501908 - Pudenz Three-Way Connector
NT8500150 - On-Off Flushing Reservoir
NT98003S01 - Peritoneal Open-Ended Catheter With Slits
NT8501125 - UltraVS Kit-Neonate (High Pressure)
NT96001S01 - Pudenz Ventricular Catheter
NT8501215 - Convertible Natus® CSF Reservoir
NT8500108 - Multi-Purpose Valve (Medium Pressure) with Anti-Siphon Device
NT8501375 - Pudenz Reflux Control Catheter
NT8501229 - Portnoy Ventricular Catheter With Stylet
NT8501110 - UltraVS - Standard (Medium Pressure)
NT8501132 - Large Rickham-Style Reservoir
NT8501213 - Convertible Natus® CSF Reservoir
NT8501192 - Braden Flushing Reservoir
NT8501113 - UltraVS Kit - Standard (Low Pressure)
NT99023S01 - Barium Impregnated Ventricular Catheter
NT8501128 - UltraVS - Neonate (High Pressure)
NT8501357 - Pudenz Flushing Valve (Medium Pressure)
NT97001S01 - Luer Connector
NT8501210 - Standard Natus® CSF Reservoir
NT8500125 - Multi-Purpose Valve (Low Pressure)
NT83026S03 - Mini Natus® CSF Reservoir Convertible
NT8501211 - Standard Natus® CSF Reservoir
NT8501221 - Pudenz Infant Cardiac Catheter (Low Pressure)
NT8501331 - Pudenz Flushing Valve (Low Pressure)
NT97105S01 - Spetzler Lumbar Peritoneal Shunt System
NT8501411 - Pudenz Flushing Valve with Anti-Siphon Device (Low Pressure)
NT8509010 - NOVUS Valve (Low Pressure)
NT8501515 - Pudenz Ventricular Catheter with Stylet
NT8501517 - Pudenz Ventricular Catheter with Stylet
NT83026S04 - Mini Natus® CSF Reservoir Dual Side-Inlet
NT8501390 - Pudenz Peritoneal Catheter Barium Impregnated Stripe (Low Pressure)
NT8500132 - Multi-Purpose Valve (High Pressure)
NT8501391 - Pudenz Peritoneal Catheter Barium Impregnated Stripe (Medium Pressure)
NT8501121 - Small Rickham-Style Reservoir
NT8501504 - Pudenz Ventricular Catheter with Stylet
NT8509620 - Novus Valve, Standard, Shunt Kit Medium Pressure
NT8501902 - Pudenz Right Angle Connector
NT8501380 - Pudenz Peritoneal Catheter (Low Pressure)
NT8501114 - UltraVS Kit - Standard (Medium Pressure)
NT8509021 - NOVUS Valve, Mini (Medium Pressure)
NT8501413 - Pudenz Flushing Valve with Anti-Siphon Device (Medium Pressure)
NT8501124 - UltraVS Kit-Neonate (Medium Pressure)
NT8501359 - Pudenz Flushing Valve (High Pressure)
NT8509011 - NOVUS Valve, Mini (Low Pressure)
NT8501381 - Pudenz Peritoneal Catheter (Medium Pressure)
NT8501919 - Double Threaded Nylon Straight Connector
NT83026S01 - Mini Natus® CSF Reservoir Standard
NT8509020 - NOVUS Valve (Medium Pressure)
NT8501900 - Pudenz Nylon Straight Connector
NT8507210 - Spetzler Lumbar Peritoneal Shunt, One Piece
NT8501202 - Pudenz Cardiac Catheter (High Pressure)
NT8500200 - Anti-Siphon Device
NT8509321 - NOVUS Valve, MINI, Shunt Kit, Medium Pressure
NT8500105 - Multi-Purpose Valve (Low Pressure) with Anti-Siphon Device
NT8509311 - NOVUS Valve, MINI, Shunt Kit, Low Pressure
NT83026S02 - Mini Natus® CSF Reservoir Side-Inlet
NT8501214 - Side-Inlet Natus® CSF Reservoir
NT8501519 - Pudenz Ventricular Catheter with Stylet
NT8501201 - Pudenz Cardiac Catheter (Low Pressure)
NT8501410 - Pudenz Flushing Valve with Anti-Siphon Device (Low Pressure)
NT8501126 - UltraVS - Neonate (Low Pressure)
NT8501376 - Pudenz Open-Ended Catheter With Slits
NT8501123 - UltraVS Kit-Neonate (Low Pressure)
NT8501109 - UltraVS - Standard (Low Pressure)
NT8501356 - Pudenz Flushing Valve (Medium Pressure)
NT80076S01 - Edwards-Barbaro Syringo-Peritoneal Shunt
NT8501412 - Pudenz Flushing Valve with Anti-Siphon Device (Medium Pressure)
NT8501127 - UltraVS - Neonate (Medium Pressure)
NT999410 - RADIOPAQUE POLYPROPYLENE STRAIGHT CONNECTORS
NT999412 - RADIOPAQUE POLYPROPYLENE "Y" CONNECTORS
NT999411 - RADIOPAQUE POLYPROPYLENE F8/F5 STEPDOWN CONNECTORS
NT999414 - RADIOPAQUE POLYPROPYLENE "T" CONNECTORS
NT999415 - RADIOPAQUE POLYPROPYLENE F8/F5 STEPDOWN CONNECTORS
NT951103 - Y-LUMBAR CATHETER F5
NT902125 - NATUS DP PEDIATRIC VALVE SYSTEM, BROWN (HIGH): 120-170 mmH2O
NT901410 - STAINLESS STEEL STRAIGHT CONNECTORS
NT955113 - BURR HOLE RESERVOIR AND SILICONE CAP (Stainless Steel - 6.4 mm - Depth 0.8 mm)
NT901143 - NATUS DP STANDARD VALVE UNIT, YELLOW (MEDIUM): 80-120 mmH2O
NT908162 - Natus DP Pediatric Burr Hole Shunt System, Brown (High): 120-170 mmH2O
NT901113 - NATUS DP STANDARD VALVE UNIT, BLUE (VERY LOW): 15-40 mmH2O
NT902123 - NATUS DP PEDIATRIC VALVE UNIT, WHITE (LOW): 40-80 mmH2O
NT901411 - STAINLESS STEEL RIGHT ANGLE CONNECTORS
NT955143 - BURR HOLE RESERVOIR AND SILICONE CAP (Stainless Steel - 10 mm - Depth 0.8 mm)
NT901125 - NATUS DP STANDARD VALVE SYSTEM, WHITE (LOW): 40-80 mmH2O
NT901145 - NATUS DP STANDARD VALVE SYSTEM, YELLOW (MEDIUM): 80-120 mmH2O
NT901182 - NATUS DP STANDARD VALVE SYSTEM, GREEN (VERY HIGH): 170-230 mmH2O
NT901162 - NATUS DP STANDARD VALVE SYSTEM, BROWN (HIGH): 120-170 mmH2O
NT901123 - NATUS DP STANDARD VALVE UNIT, WHITE (LOW): 40-80 mmH2O
NT901163 - NATUS DP STANDARD VALVE UNIT, BROWN (HIGH): 120-170 mmH2O
NT903440 - Gravity Compensating Accessory, High Pressure Range (Brown)
NT902525 - NATUS DP PEDIATRIC VALVE SYSTEM, BROWN (HIGH): 120-170 mmH2O
NT907142 - Natus DP Standard Burr Hole Shunt System, Yellow (Medium): 80-120 mmH2O
NT955141 - BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Stainless Steel - 10 mm - Depth 0.8 mm)
NT955112 - BURR HOLE RESERVOIR AND SILICONE CAP (Stainless Steel - 6.4 mm - Depth 2.5 mm)
NT908122 - Natus DP Pediatric Burr Hole Shunt System, White (Low): 40-80 mmH2O
NT901414 - STAINLESS STEEL "T" CONNECTORS
NT955110 - BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Stainless Steel - 6.4 mm - Depth 2.5 mm)
NT901412 - STAINLESS STEEL "Y" CONNECTORS
NT908142 - Natus DP Pediatric Burr Hole Shunt System, Yellow (Medium): 80-120 mmH2O
NT955111 - BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Stainless Steel - 6.4 mm - Depth 0.8 mm)
NT901165 - NATUS DP STANDARD VALVE SYSTEM, BROWN (HIGH): 120-170 mmH2O
NT901183 - NATUS DP STANDARD VALVE UNIT, GREEN (VERY HIGH): 170-230 mmH2O
NT903435 - Gravity Compensating Accessory, Medium Pressure Range (Yellow)
NT955140 - BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Stainless Steel - 10 mm - Depth 2.5 mm)
NT903430 - Gravity Compensating Accessory, Low Pressure Range (White)
NT907162 - Natus DP Standard Burr Hole Shunt System, Brown (High): 120-170 mmH2O
NT902045 - NATUS DP PEDIATRIC VALVE SYSTEM, WHITE (LOW): 40-80 mmH2O
NT907122 - Natus DP Standard Burr Hole Shunt System, White (Low): 40-80 mmH2O
NT955142 - BURR HOLE RESERVOIR AND SILICONE CAP (Stainless Steel - 10 mm - Depth 2.5 mm)
NT908112 - Natus DP Pediatric Burr Hole Shunt System, Blue (Very Low): 15-40 mmH2O
NT902080 - NATUS DP PEDIATRIC VALVE SYSTEM, YELLOW (MEDIUM): 80-120 mmH2O
NT901112 - NATUS DP STANDARD VALVE SYSTEM, BLUE (VERY LOW): 15-40 mmH2O
NT901122 - NATUS DP STANDARD VALVE SYSTEM, WHITE (LOW): 40-80 mmH2O
NT902545 - NATUS DP PEDIATRIC VALVE SYSTEM, WHITE (LOW): 40-80 mmH2O
NT901142 - NATUS DP STANDARD VALVE SYSTEM, YELLOW (MEDIUM): 80-120 mmH2O
NT902580 - NATUS DP PEDIATRIC VALVE SYSTEM, YELLOW (MEDIUM): 80-120 mmH2O
NT902012 - NATUS DP PEDIATRIC VALVE SYSTEM, BLUE (VERY LOW): 15-40 mmH2O
Camino Flex Ventricular Intracranial Pressure Monitoring Kit
Micro Ventricular Bolt Pressure/Temperature Monitoring Kit, model 110-4HMT
NT901118 - PERITONEAL INTRODUCER SHEATHS, 46 cm
NT990012 - PERITONEAL INTRODUCER SHEATHS, 31 cm
NT9MD1241 - PERITONEAL INTRODUCER SHEATHS, 81 cm
NT901124 - PERITONEAL INTRODUCER SHEATHS, 61 cm
NT9MD170 - PERITONEAL INTRODUCER SHEATH, 70 cm (27.5 Inches)
NT999007 - Radiopaque Silicone Suturable Tubing Clamps For Natus F8 Catheter
NT999005 - Radiopaque Silicone Suturable Tubing Clamps For Natus F5 Catheter
NT999004 - Radiopaque Silicone Suturable Tubing Clamps For Natus F7 Catheter
NT901415 - STAINLESS STEEL F8/F5 STEPDOWN CONNECTORS
Micro Ventricular Bolt Pressure Monitoring Kit, model 110-4HM
NT901212 - STAINLESS STEEL PERITONEAL INTRODUCER, 31 cm
NT901224 - STAINLESS STEEL PERITONEAL INTRODUCER, 61 cm
NT901218 - STAINLESS STEEL PERITONEAL INTRODUCER, 46 cm
NT9MD270 - STAINLESS STEEL PERITONEAL INTRODUCER, 70 cm
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device