FDA.reportPublic FDA data

Natus

Primary DI
00382830025331
Brand
Natus
Company
Embla Systems Ltd
Model
1411516
Device description
Snap On Cable 39in/100cm Green
Published
2019-10-29
Public version status
New
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
K172703000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172703000Disposable Snap ElectrodeEmbla Systems2017-11-13GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830025331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830025331003828300253313828300253310382830025331

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203408612
Device count
1
Lot or batch
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
00382830023924Xltek41200822016-10-24

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