FDA.reportPublic FDA data

RXi® Cable

Primary DI
30841716102692
Brand
RXi® Cable
Company
ACIST MEDICAL SYSTEMS, INC.
Model
018748
Device description
Meritrans Ao Interface Transducer Cable, P/N 301859-001
Published
2020-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OBICatheter, Pressure Monitoring, Cardiac

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBICatheter, Pressure Monitoring, CardiacCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132474000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132474000CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETERAcist Medical Systems2014-01-30DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841716102692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084171610269230841716102692

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841716102704ACIST VeraPro HiFi 1650188042026-05-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841716103244ACIST Navvus®II CatheterACIST MEDICAL SYSTEMS, INC.OBI2025-01-20
30841716102845RXi® Console CableACIST MEDICAL SYSTEMS, INC.OBI2021-06-17
10841716102483ACIST Navvus®II CatheterACIST MEDICAL SYSTEMS, INC.OBI2020-05-12
30841716102180RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2019-01-16
30841716102067RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2018-09-26
30841716102074RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2018-09-26
10841716101738ACIST RXi® SystemACIST MEDICAL SYSTEMS, INC.OBI2018-08-02
30841716101732ACIST RXi® SystemACIST MEDICAL SYSTEMS, INC.OBI2018-08-02
40841716101746ACIST RXi® System and AccessoriesACIST MEDICAL SYSTEMS, INC.OBI2018-08-02
30841716102012RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2018-02-20
30841716100360RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2017-08-17
30841716100377RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2017-08-17
30841716101701RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2017-08-17
30841716101718RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2017-08-17
30841716101725RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2017-08-17
40841716100732ACIST RXi® System and AccessoriesACIST MEDICAL SYSTEMS, INC.OBI2017-02-17
10841716101448ACIST RXi® Ao Interface BoxACIST MEDICAL SYSTEMS, INC.OBI2016-12-08
40841716100664ACIST RXi® System and AccessoriesACIST MEDICAL SYSTEMS, INC.OBI2016-10-13
10841716100588ACIST RXi® Bed Rail MountACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
10841716100595ACIST RXi® CartACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
10841716101257ACIST RXi® SystemACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100384ACIST RXi® SystemACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100391RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100407RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100414RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100421RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100438RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100445RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100452RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09
30841716100469RXi® CableACIST MEDICAL SYSTEMS, INC.OBI2016-09-09