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
2333451718927588K252377NxStage System One with NxViewKDI2026-05-15
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
2333451783571847
2333451848642188
2333452013832094
2333452016998166

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDI172026-05-15
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