FDA.reportPublic FDA data

VPS Rhythm DLX Ultrasound Probe, Rebuilt

Primary DI
00850921007271
Brand
VPS Rhythm DLX Ultrasound Probe, Rebuilt
Company
INTERSON CORP
Model
SP-DLX200
Catalog number
DLX-200-USP-R
Device description
VPS Rhythm DLX Ultrasound Probe, Rebuilt
Published
2020-10-30
Public version status
New
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
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850921007271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850921007271008509210072718509210072710850921007271

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-246-6990CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
079884004
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850921007257VPS Rhythm DLX Ultrasound ProbeSP-DLX200DLX-200-USP2020-10-30
00850921007202I-Streme Echo Ultrasound Softwarex.x2017-10-23
00850921007004IntersonGP-C0199-79032017-04-27
00850921007011SeeMoreEC 7.5 MHz99-59312016-08-03
00850921007028SeeMoreGP 3.5 MHz99-59292016-08-03
00850921007035SeeMoreViewBladder 1099-90082016-08-03
00850921007042SeeMoreVC 7.5 MHz99-59302016-08-03
00850921007059SeeMorePI 7.5 MHz99-55442018-03-02
00850921007066SeeMore Software2.0.03 URO98-3517-022016-08-29
00850921007073SeeMoreMV 12 MHz99-59342016-08-22
00850921007080SeeMoreGP 200099-87842016-08-29
00850921007097SeeMoreES 12.0 MHz99-55382016-08-29
00850921007103SeeMore Software2.0.03 GEN98-3517-002016-08-29
00850921007110SeeMore Software2.0.03 OB GYN98-3517-032016-08-29
00850921007127IntersonSP-L0199-79012017-04-27
00850921007134SeeMore ViewBladder 10 Software2.0.03 ViewBladder98-3518-002016-08-29
00850921007141SeeMore Software4.2.1 OB GYN98-3528-012016-08-29
00850921007158SeeMore Software4.2.1 GEN98-3528-022016-08-29
00850921007165SeeMore Software4.2.1 URO98-3528-032016-08-29
00850921007172SeeMore Software4.4.x2017-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953121382VolusonGE Ultrasound Korea Ltd.IYN2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08033737713037THD Procto Software SystemTHD SPAITX2021-07-19
08052461860046Echolight S.p.a.ECHOLIGHT SPAIYO2021-03-05
08056304453891E 3-12ESAOTE SPAITX2019-12-20
08056304454096C 2-9ESAOTE SPAITX2019-12-20
08056304453419MyLabX8ESAOTE SPAIYN2019-12-20
08056304453419MyLabX8ESAOTE SPAIYO2019-12-20
08056304453518MyLabX6ESAOTE SPAIYN2019-06-13
08056304453518MyLabX6ESAOTE SPAITX2019-06-13
08056304453525MyLabX7ESAOTE SPAIYO2019-06-13
08056304453525MyLabX7ESAOTE SPAITX2019-06-13
08056304453563MyLabX5ESAOTE SPAIYO2019-06-13
08056304453563MyLabX5ESAOTE SPAITX2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYO2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYN2019-06-13
08056304453679MyLabSigmaESAOTE SPAIYO2019-06-13
08056304453679MyLabSigmaESAOTE SPAIYN2019-06-13
08056304453921MyLab 9ESAOTE SPAIYN2019-06-13
08056304453921MyLab 9ESAOTE SPAITX2019-06-13
08056304452658MyLab 9 eXPESAOTE SPAITX2018-02-19
08056304452658MyLab 9 eXPESAOTE SPAIYN2018-02-19
08056304452603MyLabEight eXPESAOTE SPAIYO2017-04-03
08056304452603MyLabEight eXPESAOTE SPAIYN2017-04-03
08056304452610MyLabEightESAOTE SPAITX2017-04-03
08056304452610MyLabEightESAOTE SPAIYO2017-04-03
08056304452597MyLabSeven ESAOTE SPAITX2017-02-24
08056304452597MyLabSeven ESAOTE SPAIYO2017-02-24
08056304453013MyLabOneEsaote Europe B.V.ITX2017-02-24