FDA.reportPublic FDA data

ACIST RXi® Mini Mount

Primary DI
10841716101769
Brand
ACIST RXi® Mini Mount
Company
ACIST MEDICAL SYSTEMS, INC.
Model
018594
Device description
RXi Mini Mounts p/n 701601-008
Published
2017-09-27
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
DRQAmplifier And Signal Conditioner, Transducer Signal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRQAmplifier And Signal Conditioner, Transducer SignalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172216000ACIST RXi Mini SystemAcist Medical Systems, Inc.2017-08-18DRQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841716101763PackageGS11In Commercial Distribution
10841716101769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084171610176330841716101763
1084171610176910841716101769

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac catheterization laboratory computerA dedicated computer designed to calculate, store, and analyse haemodynamic parameters, and other cardiac-related measurements, based on data from catheterization laboratory monitoring/recording. Such data can be pressure measurements that are converted into useful parameters, e.g., cardiac output, pressure gradients, valve areas, shunt flows, vascular resistance, diastolic filling period or systolic ejection period. The computer may store these values chronologically, along with other physiologic events that occur during the procedure. This GMDN code may reflect old technology; its functions may be performed using off-the-shelf computer ware and dedicated software.

Regulatory Flags#

DUNS number
926684994
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10841716102728ACIST VeraPro FLX 1650188062026-05-26
10841716102742ACIST VeraPro S100 Multi-Use Syringe0188082026-05-26
10841716102773ACIST VeraPro S100 LV1 Low-Viscosity Syringe0188112026-05-26
10841716102803ACIST VeraPro AMT Auto-Manifold and Transducer0188142026-05-26
10841716103992ACIST HDi™ Cart0179912026-03-04
10841716103442CT Exprès Bottle Spike A6404582025-12-09
10841716103466CT Exprès Day Set III HP6404602025-12-09
10841716101561BT2000 Automated Manifold Kit0146132020-11-06
10841716101943A2000 Multi-use Syringe Kit0146122018-06-06
10841716101974BT2000 Automated Manifold Kit0146132018-06-06
10841716101998AngioTouch® Kit0146442018-06-06
10841716102001AngioTouch® Kit0146452018-06-06
10841716102155A1000 Single Use Syringe Kit0166062019-10-09
10841716102162Single-use Syringe Kit0166052019-10-16
10841716102520A1000V Single Use Syringe Kit0166052024-05-28
10841716102544A2000 Multi-use Syringe Kit0146122020-11-06
10841716102605A1000 Single Use Syringe Kit0166062020-11-06
10841716102612Single-use Syringe Kit0166052020-11-06
10841716101875ACIST CVi® Contrast Delivery System Injector Head0162242018-06-13

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Primary DI, Brand, Company table
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00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
08714729882985LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
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08714729885962LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
40841716101586ACIST RXi® Mini System OverpackACIST MEDICAL SYSTEMS, INC.DRQ2019-05-06
00884838020849SO2 Optical ModulePhilips Medizin Systeme Böblingen GmbHDRQ2018-12-18
10841716101783ACIST RXi® Mini Processing UnitACIST MEDICAL SYSTEMS, INC.DRQ2017-09-27
10841716101790ACIST RXi® Mini Navvus InterfaceACIST MEDICAL SYSTEMS, INC.DRQ2017-09-27
30841716101770RXi® Mini Navvus Interface CableACIST MEDICAL SYSTEMS, INC.DRQ2017-09-27