FDA.reportPublic FDA data

Natus

Primary DI
00382830059305
Brand
Natus
Company
XLTEK
Model
017264
Device description
Quantum Breakout Roll Stand
Published
2021-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180181000Natus QuantumNatus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)2018-02-22GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830059305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830059305003828300593053828300593050382830059305

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring system, portableA mains electricity (AC-powered) device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function. It may be capable of monitoring various other physiological paramenters such as electromyogram (EMG), respiration wave forms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG. It includes a control unit, electrodes, and components (e.g., amplifier, cables, probes); it is designed to be easily moved and is commonly used at the patient's bedside, in an intensive care unit (ICU), or an examination room.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
245258280
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830023955Natus20130012025-02-27
00382830023986Natus20400012025-02-27
00382830059251Natus20200112025-02-27
00382830062466Natus60-0000702024-09-30
00382830016896Natus61-0004002021-06-22
00382830056335Natus61-0003002021-06-22
00382830058674Natus60-0000902021-06-22
00382830058681Natus60-0000922021-06-22
00382830060110NatusRETCAM-FA-UPGRADE2021-06-22
00382830002424Natus103282016-09-13
00382830002950Natus103592016-09-13
00382830003063Natus1027622016-09-13
00382830003155Natus1040372016-09-13
00382830022316GrassCMXL-PLUS-ECMXL-PLUS-E2018-07-13
00382830022323GrassCMXL-E-SPCCMXL-E-SPC2018-07-13
00382830022330GrassCMXL-E-APCCMXL-E-APC2018-07-13
00382830022347GrassCM-PLUS-ECM-PLUS-E2018-07-13
00382830022392GrassCMXL-PLUS-PCMXL-PLUS-P2018-07-13
00382830022408GrassCMXL-P-NCCMXL-P-NC2018-07-13
00382830022415GrassCMXL-P-APCCMXL-P-APC2018-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973602730894MEDLOTTOP-RANK HEALTH CARE CO., LTD.GXY2026-06-08
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
00850055335004iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335011iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335028iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02