FDA.reportPublic FDA data

ACIST CVi® Adjustable Arm

Primary DI
30841716100186
Brand
ACIST CVi® Adjustable Arm
Company
ACIST MEDICAL SYSTEMS, INC.
Model
0146CC
Device description
CVi Adjustable Arm, p/n 800625-001
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DXTInjector And Syringe, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841716100186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084171610018630841716100186

GMDN Terms#

Term, Definition table
TermDefinition
Angiography contrast medium injection system, line-powered, mobileAn assembly of devices designed to inject contrast media through a small catheter and into the vascular system for angiographic procedures (e.g., examination of the coronary and renal arteries, and great vessels and vasculature of the heart, brain, abdominal organs, and extremities). It consists of mains electricity (AC-powered) electromechanical injectors (electric motor connected to a jackscrew that moves a syringe piston) with syringes capable of delivering media with the pressure, flow range, and volume required for angiographic studies, and is mobile (e.g., on a wheeled pedestal). Some types can synchronize media delivery with the electrocardiographic cycle and/or the x-ray generator.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
926684994
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10841716101875ACIST CVi® Contrast Delivery System Injector Head0162242018-06-13
10841716101882ACIST CVi® Contrast Delivery System Injector Head0162252018-06-13
10841716101899ACIST CVi® Contrast Delivery System Control Panel0162272018-06-13
10841716101905ACIST CVi® Contrast Delivery System Power Supply0162262018-06-13
10841716103480CT Exprès Patient Set6404572025-08-15
10841716103602ACIST Kodama® Coronary Imaging Catheter0177882025-08-14
10841716103244ACIST Navvus®II Catheter0166752025-01-20
10841716103763ACIST RXi® Console with dPR0199942025-01-20
40841716103757ACIST RXi® System with dPR0199952025-01-20
30841716103514ACIST HDi® System Console0179872024-11-13
30841716103521ACIST HDi® Power Supply0179902024-11-13
40841716103511ACIST HDi® HD IVUS System0179862024-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841716102704ACIST VeraPro HiFi 165ACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102728ACIST VeraPro FLX 165ACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102742ACIST VeraPro S100 Multi-Use SyringeACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102773ACIST VeraPro S100 LV1 Low-Viscosity SyringeACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102803ACIST VeraPro AMT Auto-Manifold and TransducerACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
00884450435533Merit Medical®Merit Medical Systems, Inc.DXT2026-05-23
10884450121433Merit Medical®Merit Medical Systems, Inc.DXT2026-01-13
00616258020419MEDRAD® Mark 7 Arterion Injection SystemBayer Medical Care Inc.DXT2025-12-19
40616258021247MEDRAD® VFLOW Sterile Disposable Hand ControllerBayer Medical Care Inc.DXT2025-12-19
00616258025186MEDRAD® Stellant CT Injection SystemBayer Medical Care Inc.DXT2025-12-10
00616258027333MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationBayer Medical Care Inc.DXT2025-12-10
49345390003538MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-12-10
26938327901909DeRoyalShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-28
26938327909189Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
16938327909199Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
16938327909205Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
26945764400148AntmedShenZhen Antmed Co., LtdDXT2025-09-17
26945764400162AntmedShenZhen Antmed Co., LtdDXT2025-09-17
50628725095078MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095085MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095108MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095160MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095177MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095184MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095191MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095214MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
09345390003356MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-08-18
00628725095066MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15
50628725095153MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15
50628725095207MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15