FDA.reportPublic FDA data

NATUS NEUROLOGY

Primary DI
00382830028301
Brand
NATUS NEUROLOGY
Company
NATUS NEUROLOGY INCORPORATED
Model
X1B013
Device description
3MHZ DOPPLER PROBE,PD2
Published
2016-09-15
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
HEPMonitor, Blood-Flow, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEPMonitor, Blood-Flow, UltrasonicObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830028301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830028301003828300283013828300283010382830028301

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system probeA hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
874257488
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830029131NATUS NEUROLOGY S-019-4749002016-09-15
00382830051910Natus0487782026-02-18
00382830038751Natus 041-7040002016-09-15
00382830032759Natus982A05972025-02-06
00382830032872Natus982A05692025-02-06
00382830034357Natus842-6483002025-02-06
00382830034395Natus842-6479002025-02-06
00382830035002Natus828-0697002025-02-06
00382830035019Natus828-0695002025-02-06
00382830035026Natus828-0694002025-02-06
00382830035033Natus828-0693002025-02-06
00382830036153Natus688-6286002025-02-06
00382830036160Natus688-6285002025-02-06
00382830044998Natus0469582025-02-06
00382830045070Natus688-6303002025-02-06
00382830045087Natus688-6304002025-02-06
00382830046916Natus0176062025-02-06
00382830046930Natus0176082025-02-06
00382830046947Natus017609 2025-02-06
00382830051385Natus0433122025-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B632MDB01009MedibluMEDIBLU MEDICAL LLCHEP2020-06-25
B510PD1000PRO1ADVANCED POCKET DOPPLERADVANCED INSTRUMENTATIONS, INC.HEP2020-04-17
B510PD100PRO1ADVANCED POCKET DOPPLERADVANCED INSTRUMENTATIONS, INC.HEP2020-04-17
GYNXD12500Sonotrax Pro Fetal DopplerGYNEX CORPORATIONHEP2017-01-19
GYNXDB12450Sonotrax Basic Fetal DopplerGYNEX CORPORATIONHEP2017-01-19
40612479199628McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199635McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199642McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199710McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199727McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
40612479199734McKessonMCKESSON MEDICAL-SURGICAL INC.HEP2016-12-09
00888937010312MediChoiceCoopersurgical, Inc.HEP2016-09-23
00815871020367E-STAvanteHEP2016-09-23
00815871020374E-STAvanteHEP2016-09-23
00815871020381E-STAvanteHEP2016-09-23
00815871020398E-STAvanteHEP2016-09-23
00815871020404E-STAvanteHEP2016-09-23
00815871020411E-STAvanteHEP2016-09-23
00815871020428E-STAvanteHEP2016-09-23
00815871021494E-ST ProAvanteHEP2016-09-23
00382830028011NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-23
00382830028004NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-21
00382830028172NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-21
00382830028189NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-21
00382830028288NATUS NEUROLOGY NATUS NEUROLOGY INCORPORATEDHEP2016-09-15
00382830028295NATUS NEUROLOGYNATUS NEUROLOGY INCORPORATEDHEP2016-09-15
00888937010299MediChoiceCoopersurgical, Inc.HEP2016-09-14
00888937010305MediChoiceCoopersurgical, Inc.HEP2016-09-14
06944413800120Ultrasonic Pocket DopplerEdan Instruments, Inc.HEP2016-09-01
06944413800137Ultrasonic Pocket DopplerEdan Instruments, Inc.HEP2016-09-01