FDA.reportPublic FDA data

Denise Oppermann

Matched from indexed company URL: DENISE OPPERMANN

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96118233002807005Denise Oppermann1N2026-01-01920 Winter St Waltham MA US 02451
96118243002806960Denise Oppermann1N2026-01-01920 Winter St North Waltham MA US 02451
96162773003244997DENISE OPPERMANN1N2026-01-01920 Winter St North Waltham MA US 02451
30123641953012364195DENISE OPPERMANN1N2026-01-01920 Winter St. Waltham MA US 02451
30153350383015335038Denise Oppermann1N2026-01-01920 Winter St Waltham MA US 02451
30357085073035708507Denise Oppermann1N2026-01-01920 Winter St North Waltham MA US 02451
30430141363043014136Denise Oppermann1N2026-01-01920 Winter St North Waltham MA US 02451

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2252231009644882K962081COMBILINES HEMODIALYSIS BLOOD TUBING SETFJK1996-11-01
94131678469843K944767DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTERFIP1995-11-29
3363441678469843K944767DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTERFIP1995-11-29
94131090289636K921134FRESENIUS POLYSULFONE DIALYZERSKDI1993-12-02
2252231443188506K915628DEXTROLYTE II PERITONEAL DIALYSIS PUMPKDJ1992-03-16
2252232036418303K904806CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTORKDJ1991-01-11
2252232037481116K896764UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5KDJ1990-02-26
2252231200009019K822550SAFE LOCK TITANIUM ADAPTER SETFKX1982-10-13
2252231224114006K822546SAFE LOCK SEALING CAPSFKX1982-10-13
2252231287709579K822543CAPD SAFE LOCK TRANSFER SETFKX1982-10-13
2252231579141212K811986THE AMP 80/2 PEDIATRIC CYCLER SYSTEMFKX1981-08-31
94131781662731K253518FX CorAL 40; FX CorAL 50KDI2025-12-18
2850151018000443K252180Bicarby 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
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
94131916081967K252180Bicarby 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
94131353571376K251851DIASAFEplusUS (F00013010)FIP2025-10-09
2252231534126491K250404stay•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
94132012938936K243874FX 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
2850151386783212K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)KPO2025-04-04
2252231715745078K2435055008X Hemodialysis SystemKDI2025-05-30
3363442042201781K2435055008X Hemodialysis SystemKDI2025-05-30
94142042201781K2435055008X Hemodialysis SystemKDI2025-05-30
3452542042201781K2435055008X Hemodialysis SystemKDI2025-05-30
94132042201781K2435055008X Hemodialysis SystemKDI2025-05-30
2850151313277838K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)KPO2024-05-10
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
94131787097501K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504KPO2023-12-01
3363442042101999K232953AquaBplus; AquaB LITEFIP2024-06-13
2252231114709229K2315345008X Hemodialysis SystemKDI2024-02-02
3452541180042780K2315345008X Hemodialysis SystemKDI2024-02-02
3363441180042780K2315345008X Hemodialysis SystemKDI2024-02-02
94131180042780K2315345008X Hemodialysis SystemKDI2024-02-02
2252231370941560K2229522008T BlueStar Hemodailysis MachineKDI2022-10-27
3452541865982715K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000KDI2023-05-11
94131865982715K220721FX 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
2252231413774632K213992CombiSet Hemodialysis Blood Tubing SetFJK2023-05-31
3363441378576885K213507AquaAFIP2022-07-27
2252231726989893K201207CombiSet 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
3363441153894269K191407Novalung SystemQJZ2020-02-21
2252231567630452K173718Liberty Cycler SetFKX2018-05-01
2252231957102242K173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetKDJ2018-02-14
2252231055070394K173593stay•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
2252231440169474K173363Cycler Drain Bag SetKDJ2018-01-24
3363441020650884K162716bibagKPO2017-05-18
2252231502160313K152953CRIT-LINE CLIP (CLIC) BLOOD CHAMBERKOC2015-11-05
3363441087753780K143617AquaC UNO HFIP2015-10-19
2252231411997792K141997CRIT-LINE IV SYSTEMKOC2015-04-01
2252231832003599K141145LIBERTY PDX CYCLERFKX2014-07-30
3363442038531414K133829AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HFFIP2014-04-22
2252232026515121K124024APD LUER-LOCK ADAPTERKDJ2013-09-19
2252231286801815K121599CRIT-LINE CLIP (CLIC)KOC2012-11-09
2252231746372367K120823BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORSFJK2012-06-15
2252231510810106K083542FRESENIUS STERILE STAY SAFE CAPKDJ2008-12-29
3363441667226382K083542FRESENIUS STERILE STAY SAFE CAPKDJ2008-12-29
2252231683716697K070049FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTORONW2011-02-03
2252231528941497K043363FRESENIUS LIBERTY CYCLERFKX2005-03-31
2252231486357218K022536\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTORKOC2002-10-30
2252231161009327K022412FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTORKDJ2003-03-05
2252231417225464K010268FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9KOC2001-04-27
2252231309175448K003445FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2FIB2000-12-01
2252231461704573K002892FRSENIUS PD IQCARD CYCLERFKX2001-04-05
2252231597627448K001873HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0FJK2000-07-28
2252231948775068K001107FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)FJK2000-06-23
2252231620433036K000451FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290FJK2000-05-09
94121020650884
2252231626613194
94131667226382
2252231727184474
2850151819576658

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDI172025-12-18
KDJ112025-04-03
KPO92025-09-09
FKX82018-05-01
FIP72025-10-09
FJK62023-05-31
KOC62020-09-18
QJZ12020-02-21
ONW12011-02-03
FIB12000-12-01