FDA.reportPublic FDA data

BladderScan®

Primary DI
00879123005564
Brand
BladderScan®
Company
VERATHON INC
Model
BVI 6000 Series
Catalog number
0570-0355
Published
2016-09-24
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
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022153000BLADDERSCAN BVI 6100Diagnostic Ultrasound Corp.2002-08-15IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00879123005564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00879123005564008791230055648791230055640879123005564

GMDN Terms#

Term, Definition table
TermDefinition
Bladder ultrasound imaging transducerAn ultrasound imaging transducer assembly specifically designed to be positioned within the bladder either manually or under endoscopic guidance. Included is a variety of single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. Also referred to as a bladder, or urethra probe, it may incorporate a biopsy needle guidance channel as part of the transducer casing or housing assembly design. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
130598584
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840432200216BladderScan®BladderScan® Carrying Case0800-07192026-07-22
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
00879123001948BladderScan®BVI 94000620-03402016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436127028Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436127035Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125311CIV-Clear™ Transducer CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125915Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125939Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125953Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127056Cable SleeveCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127186Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYO2026-07-24
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGITX2026-07-24
04987670106088CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-07-24
00841436122061Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436122672Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125338Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125444CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23