FDA.report

Bladder Scanner

Primary DI
06974784890079
Brand
Bladder Scanner
Company
Xuzhou Kaixin Electronic Instrument Co., Ltd.
Model
BVT02
Published
2024-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06974784890079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06974784890079069747848900796974784890079

GMDN Terms

TermDefinition
Bladder volume ultrasound imaging systemAn assembly of portable, battery-powered devices designed for the extracorporeal ultrasound measurement of the male or female urinary bladder volume. It typically consists of an electronic measuring and imaging display unit with a connected ultrasound transducer which together reproduce digitized data of the bladder, typically bladder volume and post-void residual (PVR), and images. It will generate ultrasound pulses, direct them to a the target area, detect the ultrasound echoes, and process the resulting information to produce and display static or dynamic three-dimensional (3-D) data/images. It is used in the diagnosis of urinary retention and postoperative urinary retention (POUR).

Sterilization Methods

Method

Regulatory Flags

DUNS number
545276982
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D510DUS6000ADVANCED DIGITAL PORTABLE ULTRASONIC SYSTEM ADVANCED INSTRUMENTATIONS, INC.IYO2026-03-24
10841716103992ACIST HDi™ CartACIST MEDICAL SYSTEMS, INC.IYO2026-03-04
04987670102813DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-03-01
06975345060108Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.IYO2026-01-31
16978669290012Astrasono A5Pro Bladder ScannerAstrasono technology co.,ltd.IYO2026-01-15
20841436126346Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00198953042816LOGIQGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-12-05
00841517112141Sonosite MTFUJIFILM SONOSITE, INC.IYO2025-11-24
00841517112196Sonosite MTFUJIFILM SONOSITE, INC.IYO2025-11-24
16978669290005Astrasono A3Pro Bladder ScannerAstrasono technology co.,ltd.IYO2025-11-20
00198953001431Venue GoGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-11-17
00198953079256VscanGE Vingmed Ultrasound ASIYO2025-11-17
00845225012984Patient Interface Module (PIMr)Philips Image Guided Therapy CorporationIYO2025-08-22
06971679948945Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co.,Ltd.IYO2025-08-05
00198953001073VenueGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-07-31
00198953001097Venue GoGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-07-31
06938396400484SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400965SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
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06938396401078SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
00884838125964Lumify USB-C to USB-C Transducer cablePhilips Ultrasound LLCIYO2025-07-14
B995LI11000Velacur ONESonic Incytes Medical Corp.IYO2025-07-14