BBS Revolution™

Primary DI
00869209000200
Brand
BBS Revolution™
Company
DBMEDX INC.
Model
PD-010-0002
Catalog number
PD-010-0002
Device description
The BBS Revolution™ device is an automated bladder volume measurement device.Earlier versions of this device were distributed with labels displaying the following internal part numbers (device identifiers): PD-020-0002, PD-020-0019, PD-020-0039, and PD-020-0047.
Published
2019-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K142329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142329000BBS REVOLUTIONDbmedx, Inc.2014-12-15IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869209000200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869209000200008692090002008692090002000869209000200

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

Contacts#

Phone, Email table
PhoneEmail
720.515.6630info@dbmedx.com

Regulatory Flags#

DUNS number
827456927
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869209000224dBsonx™PD-040-0014PD-040-00142016-08-04
00869209000231Attendant® Prodigy™ Bladder ScannerPD-010-0007PD-010-00072019-03-11
00860001971439Attendant® Prodigy™ Bladder ScannerPD-010-0010PD-010-00102024-05-24
00869209000248BBS Revolution™ Rolling StandPD-040-0046PD-040-00462024-04-01

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Primary DI, Brand, Company table
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00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
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