FDA.reportPublic FDA data

Natus

Primary DI
00382830058506
Brand
Natus
Company
XLTEK
Model
CZA00037
Device description
Neonatal Sensors
Published
2021-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMBAutomatic Event Detection Software For Full-Montage ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830058506PrimaryGS10
00382830007443Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830058506003828300585063828300585060382830058506
00382830007443003828300074433828300074430382830007443

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp electrode, single-useA noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Regulatory Flags#

DUNS number
245258280
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
00850056774017NeuroMatchLVIS CORPORATIONOMB2026-05-12
05060941990018AutoscoreHolberg Eeg ASOMB2026-01-28
09120109830269encevisAIT Austrian Institute of Technology GmbHOMB2025-08-05
00850056774000NeuroMatchLVIS CORPORATIONOMB2025-04-04
00860005388189REMI VigilenzEpitel, Inc.OMB2024-03-11
00869732000166Persyst 15 EEG Review and Analysis SoftwarePersyst Development CorpOMB2023-07-24
09120109830122encevisAIT Austrian Institute of Technology GmbHOMB2022-07-15
00382830007443NatusXLTEKOMB2021-10-07
00851420007052Pocket EEG DeviceCERIBELL, INC.OMB2021-08-02
00382830058209NatusXLTEKOMB2021-04-20
00382830058216NatusXLTEKOMB2021-04-20
00382830058575NatusXLTEKOMB2021-04-20
09120109830078encevisAIT Austrian Institute of Technology GmbHOMB2021-01-11
00382830008020NatusXLTEKOMB2019-11-27
00382830010924NatusXLTEKOMB2019-11-27
00869732000128Persyst 14 Review and Analysis SoftwarePersyst Development CorpOMB2019-04-08
00869732000135Persyst Mobile App Persyst Development CorpOMB2019-04-08
00869732000142Persyst Mobile AppPersyst Development CorpOMB2019-04-08
00851420007045Pocket EEG Device, EEG Recording Viewer SoftwareCERIBELL, INC.OMB2018-03-28
00382830022231XLTEKXLTEKOMB2016-10-17
00382830002493NatusXLTEKOMB2016-09-13
00382830002516NatusXLTEKOMB2016-09-13
00382830002523NatusXLTEKOMB2016-09-13
00382830002547NatusXLTEKOMB2016-09-13
00382830002554NatusXLTEKOMB2016-09-13
00382830002677NatusXLTEKOMB2016-09-13
00382830002745NatusXLTEKOMB2016-09-13
00382830002820NatusXLTEKOMB2016-09-13
00382830009072NatusXLTEKOMB2016-09-13
00382830016643NatusXLTEKOMB2016-09-13