FDA.reportPublic FDA data

Natus

Primary DI
00382830038201
Brand
Natus
Company
NATUS NEUROLOGY INCORPORATED
Model
222-515000
Device description
PROBE/ULTRASOUND USB MV 12MHZ
Published
2016-09-19
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
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830038201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830038201003828300382013828300382010382830038201

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
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
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYO2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYO2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290031522HERA Z20e Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08800290041705miniER7SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041934LA2-9SSAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041941CMV1-10SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042184PA1-5ASAMSUNG MEDISON CO., LTD.IYO2025-12-05