FDA.reportPublic FDA data

BladderScan®

Primary DI
00879123001948
Brand
BladderScan®
Company
VERATHON INC
Model
BVI 9400
Catalog number
0620-0340
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10879123001945PackageGS11Not in Commercial Distribution
00879123001948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087912300194510879123001945
00879123001948008791230019488791230019480879123001948

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound system quality assurance deviceAn instrument used for quality assurance (QA) purposes to check the calibration and performance of systems that produce ultrasound waves used for diagnostic or therapeutic applications. This includes a variety of instruments used to measure parameters associated with beam production, beam quality, image quality and other system performance parameters.

Regulatory Flags#

DUNS number
130598584
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00879123004505BladderScan®Prime0570-03472016-09-24
00879123006493BladderScan®Prime Plus™0570-03952019-08-27
10879123005141BladderScan®Prime0270-08702016-09-24
00879123006486BladderScan®Prime Plus™0570-03942019-08-27
00879123004499BladderScan®Prime0570-03462016-09-24
00879123004239ScanPoint®ScanPoint Local Client0900-10092016-09-24
00879123006127ScanPoint®ScanPoint®2016-09-24
00879123006134ScanPoint®QuickPrint0900-12382016-09-24
00879123002259BladderScan®BVI 94000400-00662016-09-24
00879123002501BladderScan®BVI 30000620-01562016-09-24
00879123002570BladderScan®BVI 30000800-01672016-09-24
00879123002631BladderScan®BVI 94000800-03222016-09-24
00879123002969BladderScan®BVI 94000570-01932016-09-24
00879123002976BladderScan®BVI 94000570-03512016-09-24
00879123005663BladderScan®BVI 30000400-01322016-09-24
10879123001594BladderScan®BVI 30000270-02002016-09-24
10879123001754BladderScan®BVI 94000270-04042016-09-24
10879123003642BladderScan®BVI 3000C270-02002016-09-24
10879123003659BladderScan®BVI 9400U270-04042016-09-24
10879123004755BladderScan®BVI 30000270-03032016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027419LA2-9SDSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290028638CA2-8ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029390EV2-10ASAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029420CV1-8AESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.ITX2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08800289979132cV4 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
08800289970351cV8 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-02-27