FDA.reportPublic FDA data

ACIST RXi® Ao Interface Box

Primary DI
10841716101448
Brand
ACIST RXi® Ao Interface Box
Company
ACIST MEDICAL SYSTEMS, INC.
Model
018311
Device description
Ao Interface Box, p/n 701587-001Contents: Ao interface box, mounting bracket, cables
Published
2016-12-08
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
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
30841716101442PackageGS11In Commercial Distribution
10841716101448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084171610144230841716101442
1084171610144810841716101448

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
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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
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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
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30841716102845RXi® Console CableACIST MEDICAL SYSTEMS, INC.OBI2021-06-17
10841716102483ACIST Navvus®II CatheterACIST MEDICAL SYSTEMS, INC.OBI2020-05-12
30841716102692RXi® CableACIST 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
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