FDA.reportPublic FDA data

InfuSystem Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30049068723004906872InfuSystem Inc.1Y2026-01-0111130 Strang Line Rd. Lenexa KS US 66215
30123378683012337868InfuSystem Inc.1N2026-01-015035 Timberlea Blvd Unit 3 Mississauga Ontario CA L4W 2W9

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1037481712257013K991599CADD ADMINISTRATION SETFPA1999-06-15
1037481204538434K982839CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300MEA1998-11-02
1958261652195686K982839CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300MEA1998-11-02
1037481510050516K982838CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400FRN1998-11-04
1958261962732793K982838CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400FRN1998-11-04
1037481622496807K982836CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEMFRN1998-11-02
1958261697629959K982836CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEMFRN1998-11-02
1958261926930225K981816CUE AMBULATORY VOLUMETRIC INFUSION PUMPFRN1998-12-04
1037482014549289K981816CUE AMBULATORY VOLUMETRIC INFUSION PUMPFRN1998-12-04
1037481874731565K960957EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACKFRN1996-06-04
1958261945886762K960957EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACKFRN1996-06-04
1958261049153501K960826CADD-PRIZM MODEL 6100 PUMPFRN1996-08-23
1037481905148500K960826CADD-PRIZM MODEL 6100 PUMPFRN1996-08-23
1037481244964425K950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSFRN1995-06-21
1037481819709633K945942AUTO SYRINGE(R) AS50 INFUSION PUMPFRN1995-07-10
1037481290255263K941445EXTENSION SET WITH ANTI-SIPHON VALVEFPA1994-06-29
1037481056304265K931113CADD-TPN(TM) AMBULATORY INFUSION SYSTEMFIH1994-04-28
1037481337543299K915522FLO-GARD(R) 6201FRN1992-02-28
1958261522956726K890120SYRINGE INFUSION PUMPFRN1989-07-27
1037481822584027K890120SYRINGE INFUSION PUMPFRN1989-07-27
1037481832110688K232917Chemo MouthpieceQUA2024-01-23
1958261354445284K222048Spectrum IQ Infusion System with Dose IQ Safety SoftwareFRN2022-09-06
1958261250488981K211218BD Alaris System with Guardrails Suite MX v12.1.2FRN2023-07-21
1037481489357704K161667Sapphire Infusion PumpFRN2017-03-27
1958261496638271K161667Sapphire Infusion PumpFRN2017-03-27
1037481305853965K142539EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery SetPIF2015-01-08
1037481102290298K133801BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARYFRN2014-05-07
1958261382339256K133801BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARYFRN2014-05-07
1037481583234831K131154ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;LZH2014-02-12
1037481472241188K130394CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0MEA2013-12-09
1958261892065902K111275CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWAREFRN2013-02-01
1958261799908748K092313PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEMMEA2009-11-04
1037481948914351K092313PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEMMEA2009-11-04
1037482024627331K091308ALARIS PC UNIT, MODELS 8000 AND 8015FRN2009-07-09
1958262036489538K091308ALARIS PC UNIT, MODELS 8000 AND 8015FRN2009-07-09
1037481016764459K083689INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEMFRN2009-07-01
1958261164314726K083689INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEMFRN2009-07-01
1037481475280847K062233HEARTSTART MRX MONITOR/DEFIBRILLATORMKJ2006-11-22
1958261432939632K060479MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEMFRN2006-05-12
1037481880683875K042696BODYGUARD INFUSION PUMP SYSTEMFRN2005-03-11
1958262058894044K042696BODYGUARD INFUSION PUMP SYSTEMFRN2005-03-11
1037482043186507K042121SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARYFRN2004-08-26
1037481429203522K040636CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SETFPA2004-05-19
1958261827213997K040636CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SETFPA2004-05-19
1037481217996133K031361CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOPFPA2003-05-23
1958261559923931K031361CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOPFPA2003-05-23
1958261405551687K031199ENTERALITE INFINITY ENTERAL FEEDING PUMPLZH2003-07-09
1037481455840306K031199ENTERALITE INFINITY ENTERAL FEEDING PUMPLZH2003-07-09
1037481031338176K023264MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110FRN2002-12-19
1958262007857332K023264MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110FRN2002-12-19
1037481798836918K023189VISTA BASIC WITH FM SYSTEMFRN2003-03-20
1958261426680863K003029INFUSOMAT PFRN2000-12-04
1037481560564837K000842CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEMFRN2000-06-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRN352023-07-21
FPA62004-05-19
MEA52013-12-09
LZH32014-02-12
QUA12024-01-23
PIF12015-01-08
MKJ12006-11-22
FIH11994-04-28