Natus Neurology Nicolet EEG Systems

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

DANMEDIK (S) PRIVATE LIMITED

Class:

Class B medical device

Manufactured by:

Natus Neurology Incorporated

Therapeutic area:

Neurology

Therapeutic indications:

The device is intended to record, measure, store, analyze and display cerebral and extracerebral physiologic data for EEG and sleep studies with or without synchronous digital video. This data includes but is not limited to EEG, EOG, EMG, ECG, respiration, body position, snore, heart rate, oxygen saturation and other physiologic signals. All ages of patients are served, including infants either within a medical facility or outside a medical facility. It is intended for use only under the supervision of medically trained and qualified professionals who will use all available information to aid in the diagnosis of Sleep, Epilepsy and other related disorders. While the Nicolet systems are capable of displaying signals, such as Sp02 and ECG, the system is not intended for monitoring such signals for the preservation of life.

Product summary:

Models: NICOLET EEG - 982A0496, NICOLET MONITOR - 982A0479, NICOLET EEG - 982A0519, NICOLET EEG - 842-682700, Nicolet Ambulatory EEG - 982A0443, ReVue + - 982A0593, Nicolet EEG - 842-673100, NIC1 NOTEBOOK BASE - 672-608500, NIC 1 V32 AMP - 842-683100, CLAMP/AMP ARM - BLACK - 040-406200, NIC1 V32 AMP HOLDER ASSY - 472-610800, 32 CH GOLD EEG ELECTRODE STARTER KIT - 698-300400, NICONE 44CH AMP - 842-685900, HB4 HEADBOX - 515-005800, NIC1 WIN-7 VIDEO PCIe BOARD - 842-693800, Nicolet EEGWireless32A - 515-017200, 21 Inch PANEL PC ASSEMBLY - 672-613100, HB3 HEADBOX - 515-002002, NIC1 MONITOR POLE CART WITH POWER STRIP - 842-674500, ASSY/PANEL PC/AMP & HB BRKT - 515-021800, NIC1 MONITOR KEYBOARD, MOUSE, MATS - 842-674700, PTZ DOME CAM MON MNT NO CAM - 842-683600, LED MONITOR PHOTIC with ARM MOUNT - 842-683700, MEDICAL POWER OUTLETS - 842-671200, C64 Channel Amp - 842-687600, PATIENT EVENT BUTTON W/ 20IN CABLE - 085-470200, EP Electrode Starter Kit - 698-623600, 32 channel Silver EEG Electrode Starter Kit - 698-300500, 5m Compact Amp Cable - 085-461102, Adapter/Headbox White/Long, 10 per Pk - 140420, Kendall Webcol Alcohol Pads - 016-703000, BAG /NYLON 15X16.75X10 Inch CARRY - 122-413100     , Cable Micrograbber, Red & Black, 2M Lead - 085-416800, Cart Mounted Electrode Accessory Bag - 122-412100, ECI Electrode Gel 16 Oz - 122-407000, Electro Gel 128 Oz - 122-409100, Ball Electrode, Silver Chloride - 019-416700, Ball Electrode, Silver - 019-416500, Ball Electrode, Gold - 019-404900, Disposable Corkscrew Electrode - 019-476400, Single Hook-wire Electrode - 019-475300, Disposable Twisted Pair Subdermal Needle Electrode - 019-475700, Disposable 6 Color Natus Ultra Subdermal Needle Electrode - 019-476600, Disposable 6 Color Natus Ultra Subdermal Needle Electrode - 019-476800, Disposable 6 Color Natus Ultra Subdermal Needle Electrode - 019-477000, Disposable 12 Color Natus Ultra Subdermal Needle Electrode - 019-476700, Disposable 12 Color Natus Ultra Subdermal Needle Electrode - 019-476900, Disposable 12 Color Natus Ultra Subdermal Needle Electrode - 019-477100, Disposable 12 Color Subdermal Needle Electrode - 019-476200, Disposable 6 Color Subdermal Needle Electrode - 019-475900, Disposable 6 Color Subdermal Needle Electrode - 019-476100, Disposable 6 Color Subdermal Needle Electrode - 019-475800, Disposable 12 Color Subdermal Needle Electrode - 019-476300, Disposable 6 Color Subdermal Needle Electrode - 019-476000, Inline RF Filter Adaptor - 019-421500, Ball Electrode, Gold - 019-404800, PolarProbe, Stimulating or Recording - 019-400800, Reusable Extension Cable - 019-408400, Reusable Extension Cable - 019-432200, External Patient Event Button - 085-469100, EMG Surface Temperature Probe - 268-411800, Gold EEG Electrodes Starter Kit - 698-603800, Holder/EMG Probe - 071-422900, Nicolet GE Dash Vital Signs Monitor Integration Kit (1) (2) (3) - 842-687500, NicoletOne External Device Support License for Phillips Intellivue and GE Dash (3)(4) - 828-056500, Reflex Hammer - 842-116700, Pediatric Strap Kit for Carry Bag - 143-414200, Replacement Impedance Adaptor Tip, 4 per Pk - 019-428400, Re-usable Temp Probe with Ferrite, 1 per Pk - 040D040, Rhizotomy Hook Cable - 085-460000, Snap Leads 60" Cable - 019-424500, Dynamic Snore sensor / Safety DIN connectors   - 1200, Gold Ear Clip Electrode - 103095, Masimo Disposable Foam Wrap - 105515, BlueSensor R ECG Electrodes - 1410505, LM Snap On Cable - 1411520, Snap On Cable - 1411542, XactTrace Universal Cut-To-Fit Kit, Abdomen - 1421050, XactTrace Universal Cut-To-Fit Kit, Thorax - 1421051, XactTrace Universal Cut-To-Fit Kit, Compete - 1421052, Body Position Belt - 1421241, Nonin Xpod Sensor Clip - 1431530, Touchproof Adaptor 2mm - 1451010, Multiple Use Inductive Plethysmography Band - Small (2/Pack) - 4140090, Piezo Resp Effort Sensor, Infant, Beltless - 005732, Ultima Airflow Sensor - 005890, Nonin Xpod Sensor Belt Clip - 013400, 3M™ Red Dot Trace Prep - 016-400000, Test Lead Holder - 016-400700, Gauze squares - 016-400800, LemonPrep™ Skin Prep - 016-401000, TENSIVE® Conductive Adhesive Gel - 016-401600, SPECTRA® 360 Electrode Gel - 016-401800, Waveprep® Skin Prep - 016-402900, Electrode Prep Pad - 016-703200, Ten20® Conductive Paste - 016-703700, Synapse Conductive Electrode Cream - 016-703800, EMG on DVD, Volume 2 (2nd Edition), Electronic Atlas of EMG Waveforms - 017W076, EMG on DVD, Volume 2 (2nd Edition), Electronic Atlas of EMG Waveforms, CD - 017W077, EMG on DVD, Volume 1 (2nd Edition), Electronic Myoanatomic Atlas for Clinical EMG - 017W082, Disposable 4-Disk Electrodes - 019-400400, Disposable Ground Plate Electrode - 019-400500, Bipolar Electrode Replacement Pads - 019-406700, Disposable Surface Disk Electrodes - 019-408500, Disposable Disk Electrode - 019-409000, Disposable Ground Plate Electrode - 019-409100, Replacement Tubes for Tubal Insert Phones - 019-411200, Gold EEG Cup Electrodes - 019-413900, Silver EEG Cup Electrodes - 019-414100, Disposable Disk Electrodes - 019-414200, Gold EEG Cup Electrodes - 019-414400, Silver EEG Cup Electrodes - 019-414600, Disposable Disk Electrode - 019-415000, Disposable Ground and Disk Electrodes - 019-415200, Velcrom Ground Strap Electrode, Pediatric - 019-415900, Alligator Clip - 019-417000, Ground Alligator Clip - 019-417200, Silver Chloride EEG Cup Electrodes - 019-417600, Silver Chloride EEG Cup Electrodes - 019-417700, Reusable Snap Leads - 019-419000, Reusable Snap Leads - 019-419100, Reusable Snap Leads - 019-419200, Reusable Snap Leads - 019-419300, Linked Electrode Adaptor - 019-420100, Disposable Disk Electrodes - 019-420800, Snap On T-Handle For Bar Electrodes - 019-421000, Disposable 2" X 4" Ground Electrode - 019-422200, Linked Adaptor Cable - 019-425000, Single Fiber Needle Electrode - 019-425900, Single Fiber Needle Electrode - 019-426000, Disposable Center Snap 1"x1" Square Electrodes - 019-427000, Finger Clip Electrode - 019-429300, Disposable Dual SEMG/NCV Electrodes - 019-429400, Bar Electrode - 019-431400, Extension Cables Kit - 019-431500, Electrode Linker - 019-433000, Gold Cup Electrodes - 019-433800, Neuroline 715 Single Patient Surface Electrodes - 019-434600, Neuroline 715 Single Patient Surface Electrodes - 019-434700, Neuroline 715 Single Patient Surface Electrodes - 019-434800, Disposable Ground Tab Electrode - 019-435300, Disposable Ring Electrode - 019-435500, BraiNet Template Set-Up in the ICU - 019-437300, Continuous EEG in the ICU - 019-437400, BraiNet Color-Coded Template, Original, Adult/Child - 019-438200, BraiNet Color-Coded Template, Original, Adult/Child - 019-438300, BraiNet Color-Coded Template, Baby - 019-438400, BraiNet Color-CodedTemplate, Baby - 019-438500, BraiNet Color-Coded Template, Baby - 019-438600, BraiNet Color-Coded Template, Baby - 019-438700, BraiNet Color-Coded Template, Baby - 019-438800, BraiNet Color-Coded Template, 10/20, XSmall - 019-438900, BraiNet Color-Coded Template, 10/20, Small - 019-439000, BraiNet Color-Coded Template, 10/20, Child - 019-439100, BraiNet Color-CodedTemplate, 10/20, Adult - 019-439200, Disposable Ring Electrodes w/ lead - 019-439300, Disposable 3-disk Electrode Set - 019-439400, BraiNet Color-Coded Jackbox Overlay - 019-444000, Bar Electrode 30mm - 019-446700, BD 1ml Syringe Luer-Lok Tip - 019-451400, BD 3ml Syringe Luer-Lok Tip - 019-451600, PROTEX™ Disinfectant Wipes - 019-473000, Disposable EasyGrip Monopolar EMG Electrodes - 019-474800, Disposable EasyGrip Monopolar EMG Electrodes - 019-474900, Disposable EasyGrip Monopolar EMG Electrodes - 019-475000, Disposable EasyGrip Monopolar EMG Electrodes - 019-475100, Disposable EasyGrip Monopolar EMG Electrodes - 019-475200, Silver (AgAgCL) Chloride EEG Cup Electrodes - 019-477200, Silver (AgAgCL) Chloride EEG Cup Electrodes - 019-477300, Silver (AgAgCL) Chloride EEG Cup Electrodes - 019-477400, Gold (Au) EEG Cup Electrodes - 019-477500, Gold (Au) EEG Cup Electrodes - 019-477600, Gold (Au) EEG Cup Electrodes - 019-477700, Silver (Ag) Chloride EEG Cup Electrodes - 019-477800, Silver (Ag) Chloride EEG Cup Electrodes - 019-477900, Silver (AgAgCL) Chloride EEG Cup Electrodes - 019-478400, Silver (AgAgCL) Chloride EEG

Authorization date:

2016-05-06