FDA.reportPublic FDA data

Main Unit MyLabOne Double battery

Primary DI
08056304450593
Brand
Main Unit MyLabOne Double battery
Company
Esaote Europe B.V.
Model
102810091
Published
2016-09-27
Public version status
Update
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
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
08056304450593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056304450593080563044505938056304450593

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Regulatory Flags#

DUNS number
404392797
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056304453013MyLabOne1028100192017-02-24
08056304453020MyLabSix 1026420012017-02-24
08056304450043MyLabSat USA1028100182016-09-27
08056304450050SL15431220012002016-09-27
08056304450227MyLabFive4114102016-09-27
08056304450241MyLabFive BASIC UNIT4117762016-09-27
08056304450388MyLab40 eHD1022760002016-09-27
08056304450395MyLab401022760012016-09-27
08056304450401MyLab20 Plus1022760022016-09-27
08056304450425MyLab40 Basic Unit1022760042016-09-27
08056304450432MyLabSix1026420002016-09-27
08056304450470MyLabOne reg. Anestesia1028100122016-09-27
08056304450487MyLabSat1028100132016-09-27
08056304450494MyLabOne Musculoskeletal1028100142016-09-27
08056304450500MyLabOne Vascular1028100152016-09-27
08056304450517MyLabOne reg. Anestesia USA1028100162016-09-27
08056304450531MyLabTouch1028100202016-09-27
08056304450548MyLabOne Musculoskeletal USA1028100212016-09-27
08056304450555MyLabOne Vascular USA1028100222016-09-27
08056304450562MyLabTouch USA1028100232016-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056304454386MyLabX75ESAOTE SPAIYN2021-09-24
08056304454386MyLabX75ESAOTE SPAIYO2021-09-24
08033737713037THD Procto Software SystemTHD SPAITX2021-07-19
08052461860046Echolight S.p.a.ECHOLIGHT SPAIYO2021-03-05
08056304454263MyLabSigma eliteESAOTE SPAIYN2020-10-23
08056304454263MyLabSigma eliteESAOTE SPAIYO2020-10-23
08056304453891E 3-12ESAOTE SPAITX2019-12-20
08056304454096C 2-9ESAOTE SPAITX2019-12-20
08056304453419MyLabX8ESAOTE SPAIYN2019-12-20
08056304453419MyLabX8ESAOTE SPAIYO2019-12-20
08056304454126MyLabX8 eXPESAOTE SPAIYO2019-12-20
08056304454126MyLabX8 eXPESAOTE SPAIYN2019-12-20
08056304453518MyLabX6ESAOTE SPAIYN2019-06-13
08056304453518MyLabX6ESAOTE SPAITX2019-06-13
08056304453525MyLabX7ESAOTE SPAITX2019-06-13
08056304453525MyLabX7ESAOTE SPAIYO2019-06-13
08056304453563MyLabX5ESAOTE SPAITX2019-06-13
08056304453563MyLabX5ESAOTE SPAIYO2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYN2019-06-13
08056304453617MyLabOmegaESAOTE SPAIYO2019-06-13
08056304453679MyLabSigmaESAOTE SPAIYO2019-06-13
08056304453679MyLabSigmaESAOTE SPAIYN2019-06-13
08056304453921MyLab 9ESAOTE SPAITX2019-06-13
08056304453921MyLab 9ESAOTE SPAIYN2019-06-13
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