dBsonx™

Primary DI
00869209000224
Brand
dBsonx™
Company
DBMEDX INC.
Model
PD-040-0014
Catalog number
PD-040-0014
Device description
Single pack dBsonx ultrasound gel to be used with the BBS Revolution (TM) bladder scanner
Published
2016-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
20869209000228PackageGS1400In Commercial Distribution
00869209000224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086920900022820869209000228
00869209000224008692090002248692090002240869209000224

GMDN Terms#

Term, Definition table
TermDefinition
Coupling gel, non-sterileA non-sterile medium designed to be applied to a patient's unbroken skin surface to provide a coupling between an analytical device (e.g., ultrasound transducer, optical glucose monitoring system) and the patient, allowing for the emission and reception of signals (e.g., ultrasound, light) that pass through the skin during an examination. It is in the form of a non-sticky, fluid-like gel that may also assists the operator's ability to move the analytical device smoothly over the skin to better analyse the site of interest. It may be used by a healthcare professional or layperson. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
720.515.6630info@dbmedx.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869209000231Attendant® Prodigy™ Bladder ScannerPD-010-0007PD-010-00072019-03-11
00860001971439Attendant® Prodigy™ Bladder ScannerPD-010-0010PD-010-00102024-05-24
00869209000200BBS Revolution™PD-010-0002PD-010-00022019-03-11
00869209000248BBS Revolution™ Rolling StandPD-040-0046PD-040-00462024-04-01

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