Natus Medical Incorporated

FDA Device Registration & Listing · SAN DIEGO, CA, US · Registration 2023988

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2023988
FEI Number
2023988
Entity Name
Natus Medical Incorporated
City/State/Country
SAN DIEGO, CA, US
Establishment Address
6225 Nancy Ridge Dr, SAN DIEGO, CA 92121, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Natus Medical Incorporated (Owner Number: 9004873)
Owner / Operator Contact Address
3150 Pleasant View Road, Middleton, WI 53562, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K921936
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-10-03
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-10-03
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-12-12
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-10-03
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-12-12
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-12-12
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2018-10-15
GYK Instrument, Shunt System Implantation Neurology Class 1 882.4545 2020-03-06
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-10-03
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-12-12
LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular Neurology Class 2 882.5550 2019-12-12
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-10-03
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-12-12
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2020-03-06
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2020-03-06
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-12-12
PSP Intracranial Pressure & Temperature Monitoring Kit Neurology Class 2 882.1620 2019-02-12
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2018-01-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-12-12
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2018-01-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-12-12
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-12-12
GYK Instrument, Shunt System Implantation Neurology Class 1 882.4545 2019-12-12
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-10-30
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2020-03-06
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-12-12

Official Correspondent

Sanjay Mehta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Natus Medical Incorporated
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9612330 NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) OAKVILLE Ontario, CA
3010611950 Natus Neurology Incorporated Middleton, WI, US
3005581270 Natus Manufacturing Limited GORT, Co. Galway, IE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K981246 Integra Neurocare, LLC BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) 1999-05-26
K020558 Integra Neurosciences LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE 2002-03-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2023988. Last updated year: 2026. Please use registration number 2023988 when referencing this establishment in official correspondence.
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