Bladder Scanner

Primary DI
06948941160015
Brand
Bladder Scanner
Company
Meda Co., Ltd
Model
MD-6000P
Device description
MD-6000P Bladder Scanner is a hand-held ultrasonic equipment with built-in 3D mechanical sector scan probe. It is intended to measure the urine volume in human bladder. It can be connected with Tablet PC through Wi-Fi connection for medical record data transmission and management.
Published
2019-07-01
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948941160015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948941160015069489411600156948941160015

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
545188828
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948941132005Ultrasound BiomicroscopeMD-320W2021-12-18
06948941111116Ultrasonic PachymeterMD-1000P2016-09-01
06948941111123Ultrasonic Biometer for OphthalmologyMD-1000A/P2016-09-01
06948941102213Ultrasonic A/B Scanner for OphthalmologyODM-21002016-09-01
06948941102220Ultrasonic A/B Scanner for OphthalmologyODM-22002016-09-01
06948941102237Ultrasonic A/B Scanner for OphthalmologyMD-2300S 2016-09-01
06948941111109Ultrasonic Biometer for OphthalmologyMD-1000A2016-09-01
06948941160008Bladder ScannerMD-60002016-09-01

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