FDA.reportPublic FDA data

Xltek

Primary DI
00382830023849
Brand
Xltek
Company
Embla Systems Ltd
Model
2013030
Device description
Embletta MPR TX Proxy
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
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122516000EMBLETTA MPREmbla Systems2013-02-21MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830023849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830023849003828300238493828300238490382830023849

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological signal amplifierAn electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy.

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
08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08885021950136TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08720256698296Onera STS 2Onera B.V.MNR2026-05-15
08720256698302Onera STS 2Onera B.V.MNR2026-05-15
08720256698319Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.MNR2026-05-15
08720256698333Onera STS 2Onera B.V.MNR2026-05-15
08720256698340Onera STS 2Onera B.V.MNR2026-05-15
08720256698357Onera STS 2Onera B.V.MNR2026-05-15
08720256698364Onera STS 2Onera B.V.MNR2026-05-15
08720256698371Onera STS 2Onera B.V.MNR2026-05-15
08720256698463Onera STSOnera B.V.MNR2026-05-15
08720256698487Onera STSOnera B.V.MNR2026-05-15
08720256698494Onera STSOnera B.V.MNR2026-05-15
08720256698500Onera STSOnera B.V.MNR2026-05-15
08720256698517Onera STSOnera B.V.MNR2026-05-15
08720256698524Onera STSOnera B.V.MNR2026-05-15
08720256698531Onera STSOnera B.V.MNR2026-05-15
08885021950044TipTraQPRANAQ PTE. LTD.MNR2026-05-15
08885021950051TipTraQPRANAQ PTE. LTD.MNR2026-05-11
B566847001ZmachineGeneral SleepMNR2026-04-09
B566847002ZmachineGeneral SleepMNR2026-04-09
09342451002655Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002662Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002785Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDMNR2026-03-12