FDA.reportPublic FDA data

Laura Reed

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80306653002807744Laura Reed1N2026-01-01920 Winter St Waltham MA US 02451
96160743002654698Laura Reed1N2026-01-01920 Winter St Waltham MA US 02451
96162773003244997Laura Reed1N2026-01-01920 Winter St Waltham MA US 02451
30028456513002845651Laura Reed1N2026-01-01920 Winter Street Waltham MA US 02451
30055787483005578748Laura Reed1N2026-01-01920 Winter St Waltham MA US 02451
30121724163012172416Laura Reed1N2026-01-01920 Winter Street Waltham MA US 02451
30160961433016096143Laura Reed1N2026-01-01920 Winter St Waltham MA US 02451
30357085073035708507Laura Reed1N2026-01-01920 Winter St Waltham MA US 02451
30430141363043014136Laura Reed1N2026-01-01920 Winter St Waltham MA US 02451

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2333451702661745K994306REVERSOKOC2000-03-20
171281009644882K962081COMBILINES HEMODIALYSIS BLOOD TUBING SETFJK1996-11-01
2347221678469843K944767DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTERFIP1995-11-29
3363441678469843K944767DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTERFIP1995-11-29
171281443188506K915628DEXTROLYTE II PERITONEAL DIALYSIS PUMPKDJ1992-03-16
171282036418303K904806CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTORKDJ1991-01-11
171282037481116K896764UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5KDJ1990-02-26
171281200009019K822550SAFE LOCK TITANIUM ADAPTER SETFKX1982-10-13
171281224114006K822546SAFE LOCK SEALING CAPSFKX1982-10-13
171281287709579K822543CAPD SAFE LOCK TRANSFER SETFKX1982-10-13
171281579141212K811986THE AMP 80/2 PEDIATRIC CYCLER SYSTEMFKX1981-08-31
3452541916081967K252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)KPO2025-09-09
171281534126491K250404stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inchKDJ2025-04-03
3452542012938936K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)KDI2025-02-28
171271715745078K2435055008X Hemodialysis SystemKDI2025-05-30
171281715745078K2435055008X Hemodialysis SystemKDI2025-05-30
2347222042201781K2435055008X Hemodialysis SystemKDI2025-05-30
3363442042201781K2435055008X Hemodialysis SystemKDI2025-05-30
3452542042201781K2435055008X Hemodialysis SystemKDI2025-05-30
2347221787097501K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504KPO2023-12-01
3363441787097501K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504KPO2023-12-01
3452541787097501K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504KPO2023-12-01
2347222042101999K232953AquaBplus; AquaB LITEFIP2024-06-13
3363442042101999K232953AquaBplus; AquaB LITEFIP2024-06-13
1669271959574465K232926Novalung ultimate kit (US)QJZ2024-04-15
2395501959574465K232926Novalung ultimate kit (US)QJZ2024-04-15
171281114709229K2315345008X Hemodialysis SystemKDI2024-02-02
2347221180042780K2315345008X Hemodialysis SystemKDI2024-02-02
3363441180042780K2315345008X Hemodialysis SystemKDI2024-02-02
3452541180042780K2315345008X Hemodialysis SystemKDI2024-02-02
2347221865982715K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000KDI2023-05-11
3363441865982715K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000KDI2023-05-11
3452541865982715K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000KDI2023-05-11
171281413774632K213992CombiSet Hemodialysis Blood Tubing SetFJK2023-05-31
2347221378576885K213507AquaAFIP2022-07-27
3363441378576885K213507AquaAFIP2022-07-27
171271625657054K212620Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateKPO2022-05-12
171281726989893K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin LineKOC2020-09-18
2347221153894269K191407Novalung SystemQJZ2020-02-21
3363441153894269K191407Novalung SystemQJZ2020-02-21
1669271794668762K191407Novalung SystemQJZ2020-02-21
2395501794668762K191407Novalung SystemQJZ2020-02-21
171281567630452K173718Liberty Cycler SetFKX2018-05-01
171281957102242K173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetKDJ2018-02-14
171281055070394K173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inchKDJ2018-05-21
171281440169474K173363Cycler Drain Bag SetKDJ2018-01-24
171281695900215K172238CAREline Airless Hemodialysis Blood Tubing SetsKOC2017-12-14
2347221020650884K162716bibagKPO2017-05-18
3363441020650884K162716bibagKPO2017-05-18
171281502160313K152953CRIT-LINE CLIP (CLIC) BLOOD CHAMBERKOC2015-11-05
2347221087753780K143617AquaC UNO HFIP2015-10-19
3363441087753780K143617AquaC UNO HFIP2015-10-19
171281832003599K141145LIBERTY PDX CYCLERFKX2014-07-30
1669271156391924K140181MEDOS HILITE INFANT OXYGENATORDTZ2014-02-19
1669271898194636K140177MEDOS HILITE OXYGENATORDTZ2014-02-18
2347222038531414K133829AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HFFIP2014-04-22
3363442038531414K133829AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HFFIP2014-04-22
1669271512970212K133261MEDOS HILITE 7000 & 7000 LT OXYGENATORDTZ2014-01-09
2333451181589910K132602STREAMLINE EXPRESSKDI2014-02-04
171282026515121K124024APD LUER-LOCK ADAPTERKDJ2013-09-19
171281746372367K120823BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORSFJK2012-06-15
2333451669400944K113023STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZERKDI2012-12-21
2333452005077600K093069NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGEKDI2010-10-23
171281510810106K083542FRESENIUS STERILE STAY SAFE CAPKDJ2008-12-29
2347221667226382K083542FRESENIUS STERILE STAY SAFE CAPKDJ2008-12-29
3363441667226382K083542FRESENIUS STERILE STAY SAFE CAPKDJ2008-12-29
2333451083951392K080807BLOOD TUBING SETS (STERILE FLUID PATH)FJK2008-07-18
171281683716697K070049FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTORONW2011-02-03
171281528941497K043363FRESENIUS LIBERTY CYCLERFKX2005-03-31
171281402351667K041042SPLIT SEPTUM INJECTION SITESFPA2004-07-16
2333451132442289K040074ONEVIEW INTERFACEFKP2004-04-08
171281486357218K022536\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTORKOC2002-10-30
171281161009327K022412FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTORKDJ2003-03-05
171281417225464K010268FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9KOC2001-04-27
171281309175448K003445FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2FIB2000-12-01
171281461704573K002892FRSENIUS PD IQCARD CYCLERFKX2001-04-05
171281597627448K001873HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0FJK2000-07-28
171281948775068K001107FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)FJK2000-06-23
171281620433036K000451FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290FJK2000-05-09
171281727184474
171281802376684
1669271849088920
2333451900951620
2333451972009061
2333451000928583
2333451001569095
94121020650884
2333451034331741
2333451036511449
2333451039744023
2333451087267670
2333451147480381
2333451149518252
2333451189330707
2333451301023780
2333451301992030
2333451341755389
2333451622258951
171281626613194
2333451702332301
2333451718927588
2333451783571847
2333451848642188
2333452013832094
2333452016998166

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDI162025-05-30
KDJ122025-04-03
FIP102024-06-13
FKX82018-05-01
KPO72025-09-09
FJK72023-05-31
QJZ62024-04-15
KOC62020-09-18
DTZ32014-02-19
ONW12011-02-03
FPA12004-07-16
FKP12004-04-08
FIB12000-12-01