FDA.reportPublic FDA data

ACI

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20270462027046ACI MEDICAL, LLC1N2026-01-011857 DIAMOND ST SAN MARCOS CA US 92078
21342433001726808ACIST MEDICAL SYSTEMS, INC.1Y2026-01-017905 FULLER ROAD EDEN PRAIRIE MN US 55344
30083615023008361502ACIGI1Y2026-01-014399 INGOT ST Fremont CA US 94538
30120446883012044688ACIST EUROPE BV1N2026-01-01Argonstraat 3 Heerlen Limburg NL 6422PH
30309277913030927791ACIME FRAME1N2026-01-011 avenue de l'Europe Z.A. de la Maie Rinxent Pas-de-Calais FR 62720
00ACID TECH INC5Y2020-04-25107 Mercer Street New York NY US 10012
30058631773005863177ACI1N2020-04-259201 Cody -- Overland Park KS US 66214

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
527981840460361K991103MODIFICATION TO ACIST CL 100HDXT2000-05-31
527981358450926K984231ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART BDXT2000-05-31
3049461210616506K974621PERCUPUMP II WITH EDADSB1998-01-27
51741232846364K942530ART-ASSIST MODEL AA-1000JOW1996-02-28
3049461398937757K933846ANGIOGRAPHY SYRINGE KITSDXT1994-12-13
3049461649375007K932055PERCUPUMP IIFIH1995-03-21
51741968047307K903894VENAPULSE MODELS VP-25 AND VP-50JOW1991-04-03
51742059059043K903532UNNA-SLEEVE(TM)LLK1990-11-02
51741995594044K881291AIR PLETHYSMOGRAPH MODEL APG-1000DSB1988-10-14
527981583779667K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableDXT2026-05-13
527981445417599K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)DXT2026-05-13
527981835371284K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_DXO2024-07-17
527981001698103K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemDXT2020-12-17
527981180739219K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterOBJ2020-03-20
527981474675456K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOBJ2019-06-27
527982040362159K191060ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller KitDXT2019-07-18
527982046703280K190473ACIST RXi System and Navvus II CatheterOBI2019-09-13
527981774530835K173063ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOBJ2017-10-23
527982017741563K172216ACIST RXi Mini SystemDRQ2017-08-18
527981315154453K171646ACISTCVi® Contrast Delivery SystemDXT2018-02-16
51742041824595K161010HICP200 Patient/Monitor Interconnect CableGWM2016-10-20
527981068922905K151048CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient SetIZQ2016-01-22
527981114655743K132474CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETERDXO2014-01-30
51742018664458K131146ARTASSIST AND VENASSISTJOW2014-02-10
527981961410948K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESJAK2007-06-13
3049461197253683K062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730IZQ2007-04-13
527981814534919K062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730IZQ2007-04-13
671101510559860K061501FLEXO DENTAL RESIN MATERIALEBI2006-07-26
527981005095100K052744C2000 AUTOMATED MANIFOLD KITDXT2005-12-16
527982019105519K040298ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITSDXT2004-03-15
527981014189007K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825IZQ2003-06-19
527981167649499K011160E-Z EM PERCUPUMP 2001 CT INJECTORJAK2001-05-16
527981413770572K010390ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMSDXT2001-03-09
2580801083404150
2580801165416528
527981187150950
3278381023130272
3278381223014105
51741426940089
51741511647873
527981570934619
1149151576280276
527981812574291
1149152013077481
3049462013624153

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXT112026-05-13
IZQ42016-01-22
OBJ32020-03-20
JOW32014-02-10
DXO22024-07-17
JAK22007-06-13
DSB21998-01-27
OBI12019-09-13
DRQ12017-08-18
GWM12016-10-20
EBI12006-07-26
FIH11995-03-21
LLK11990-11-02

NDC#

Zolpidem

ACI Healthcare USA, Inc

Zolpidem Tartrate

Zolpidem

ACI Healthcare USA, Inc

Zolpidem Tartrate

PMN#

Applications#