FDA.reportPublic FDA data

Xltek

Primary DI
00382830023924
Brand
Xltek
Company
Embla Systems Ltd
Model
4120082
Device description
Sandman Codec Software V.2.0 CD-Elite
Published
2016-10-24
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
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830023924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830023924003828300239243828300239240382830023924

GMDN Terms#

Term, Definition table
TermDefinition
Sleep disorder interpretive softwareAn interpretive software program intended to collect and analyse patient physiological data during sleep and publish reports to assist a healthcare professional in the diagnosis of sleep disorders (e.g., insomnia, snoring, sleep apnoea) or to help evaluate treatment (e.g., positive airway pressure). It may be used as part of a complete polysomnography study using a wide range of data (e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement), or as part of a home-based study using a more limited data set [e.g., photoplethysmography (PPG) and motion tracking].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203408612
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830023764Xltek20030112016-10-24
00382830048484Embla0254062018-11-20
00382830025973Natus14210272019-10-29
00382830027205Natus14210262019-10-29
00382830026277Xltek0115222016-10-25
00382830027076Xltek14210232016-10-25
00382830027083Xltek14210322016-10-25
00382830027090Xltek14210332016-10-25
00382830027106Xltek14210342016-10-25
00382830027113Xltek14210352016-10-25
00382830027120Xltek14210362016-10-25
00382830027137Xltek14210372016-10-25
00382830027144Xltek14210382016-10-25
00382830027151Xltek14210392016-10-25
00382830027168Xltek14210412016-10-25
00382830027175Xltek14210422016-10-25
00382830027182Xltek14210432016-10-25
00382830027199Xltek14210442016-10-25
00382830027229Xltek14210402016-10-25
00382830043441Xltek0120012016-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B592SW100WAVi Scan SoftwareWAVI CO.GWQ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWQ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWQ2026-03-25
B675PDDU0Zeto ONE Display UnitZETO, INC.GWQ2025-11-19
08690020003062BrainView NeuralScanMedeia, Inc.GWQ2025-02-05
08056446900673Neurotravel LIGHTEB NEURO SPAGWQ2024-12-04
08056446900680Neurotravel LIGHT Base UnitEB NEURO SPAGWQ2024-12-04
08056446900895BE PLUS PRO LIGHTEB NEURO SPAGWQ2024-12-04
08056446900901BE PLUS PRO STANDARDEB NEURO SPAGWQ2024-12-04
08056446900918BE PLUS PRO FULLEB NEURO SPAGWQ2024-12-04
08056446900925BE PLUS PRO ADVANCEDEB NEURO SPAGWQ2024-12-04
08056446900932BE PLUS PRO Battery PackEB NEURO SPAGWQ2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAGWQ2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAGWQ2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAGWQ2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWQ2024-12-04
B675ONEECG1Zeto ONE ECG Cable Extension SetZETO, INC.GWQ2024-06-11
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.GWQ2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.GWQ2024-03-04
18437017440601Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440632Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440663Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440687Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyGWQ2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyGWQ2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyGWQ2023-04-19
00195278524089NAGE Healthcare Finland OyGWQ2023-04-19
09342451002112SiestaCompumedics Usa, Inc.GWQ2020-12-16
09342451001788SiestaCompumedics Usa, Inc.GWQ2020-12-15
00840067102824Arc EssentiaCADWELL INDUSTRIES, INC.GWQ2020-12-10