FDA.reportPublic FDA data

RAR Flexi Probe

Primary DI
EAMIRAR20810
Brand
RAR Flexi Probe
Company
AMI Agency for Medical Innovations GmbH
Model
RAR2081
Catalog number
RAR2081
Published
2018-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061831000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061831000MEDCHANNEL HTS SYSTEMMedchannel, LLC2006-08-07IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EAMIRAR20811PackageHIBCC5In Commercial Distribution
EAMIRAR20810PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system, battery-poweredA hand-held, battery-powered device assembly consisting of a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis, and the vascular states of partially severed extremities), ankle pressure index, and/or blood flow wave form recording.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length97Millimeter
Outer Diameter30Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
303655286
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EAMIICT50100i-Cut Power SupplyICT50102025-05-05
EAMIICT50110i-CutICT5011ICT50112025-05-05
EAMIICT50500i-Cut Power Supply Type AICT50502025-05-05
EAMIECI10310A.M.I. EasyClinch Disposable Tips PremiumECI1031ECI10312019-04-05
EAMIECM10110EasyClinch microECM1011ECM10112019-04-05
EAMIEDI10310A.M.I. EasyDissect Disposable Tips PremiumEDI1031EDI10312019-04-05
EAMIEDI10510A.M.I. EasyHookEDI1051EDI10512019-04-05
EAMIEDM10110EasyDissect microEDM1011EDM10112019-04-05
EAMIESI11310A.M.I. EasyShear Disposable Tips PremiumESI1131ESI11312019-04-05
EAMIESI11510A.M.I. EasyShear Mini Disposable Tips PremiumESI1151ESI11512019-04-05
EAMIESI12100Soft InsertsESI1210ESI12102019-04-05
EAMIESM10110EasyShears microESM1011ESM10112019-04-05
EAMIEVI10110ViperEVI1011EVI10112019-04-05
EAMIEAH10100EasyAct HandleEAH1010EAH10102019-04-05
EAMIEAS13100EasyAct 3 SEAS1310EAS13102019-04-05
EAMIEAS13200EasyAct 3 MEAS1320EAS13202019-04-05
EAMIEAS15100EasyAct 5 SEAS1510EAS15102019-04-05
EAMIEAS15200EasyAct 5 MEAS1520EAS15202019-04-05
EAMIEAS15300EasyAct 5 LEAS1530EAS15302019-04-05
EAMIECA10200A.M.I. HF-Cable MartinECA1020ECA10202019-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYN2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYN2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYN2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYN2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYN2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYN2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYN2026-05-28
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-04-03
08800290041934LA2-9SSAMSUNG MEDISON CO., LTD.IYN2025-12-05
08800290042665CA3-10ASAMSUNG MEDISON CO., LTD.IYN2025-12-05
08800290041699L3-22SAMSUNG MEDISON CO., LTD.IYN2025-10-13
08800290042122LA2-16SSAMSUNG MEDISON CO., LTD.IYN2025-10-13
08800290042788LA2-14ASAMSUNG MEDISON CO., LTD.IYN2025-10-13
08800290042849CA1-7SSAMSUNG MEDISON CO., LTD.IYN2025-10-13
08056304455031MyLabOmega eXPESAOTE SPAIYN2023-12-14
08056304454676MyLabX9ESAOTE SPAIYN2023-06-13
08800013544001X-CUBE 50Alpinion Medical Systems Co., Ltd.IYN2022-11-01
08800013545008X-CUBE 60Alpinion Medical Systems Co., Ltd.IYN2022-11-01
08800013511171C1-6CAlpinion Medical Systems Co., Ltd.IYN2022-07-15
08800013511164C1-7GTAlpinion Medical Systems Co., Ltd.IYN2022-02-05
08800013542007X-CUBE i8Alpinion Medical Systems Co., Ltd.IYN2022-02-05
08800013543004X-CUBE i9Alpinion Medical Systems Co., Ltd.IYN2022-02-05
08800076600119SC1FCUIYN2021-11-01
08800076600133Sono ChampionFCUIYN2021-11-01
08800076600140Sono ChangerFCUIYN2021-11-01
08800076600157Sono dot AIFCUIYN2021-11-01
08800076600010eZono1000FCUIYN2021-10-29
08800076600027Sonovation1LFCUIYN2021-10-29