FDA.reportPublic FDA data

Erika Ramsbottom

Matched from indexed company URL: Erika, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80222903000040879Erika Ramsbottom1N2026-01-0170 Commerce Center Greenville SC US 29615
80306653002807744ERIKA DE REYNOSA, S.A. DE C.V.1N2026-01-01MIKE ALLEN 1331 PARQUE INDUSTRIAL REYNOSA CD, REYNOSA Tamaulipas MX 88780
30053830853005383085Erika Martin1N2026-01-01450 Commerce Drive Quakertown PA US 18951
30239816873008730267Erika of Texas1Y2026-01-01900 W Zaragosa Dr. Suite D Pharr TX US 78577
30315654073031565407Erika de Reynosa, S.A. de C.V.1N2026-01-01Mike Allen 1392, Parque Industrial Reynosa CD, Reynosa Tamaulipas MX 88780
30087302673008730267Erika of Texas1Y2020-04-251100 E. Military Hwy Suite C Pharr TX US 78577
30166905643016690564Erika of Texas1Y2020-04-255700 South International Parkway Suite A2 McAllen TX US 78503

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
245491457463625K983267DIGORA FOR WINDOWS 2.0MUH1998-12-30
171281009644882K962081COMBILINES HEMODIALYSIS BLOOD TUBING SETFJK1996-11-01
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
245491113120081K252086DTX Studio AssistMYN2025-11-17
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
171281715745078K2435055008X Hemodialysis SystemKDI2025-05-30
3287761214018675K2432372008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)KDI2025-06-13
245491652332438K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)OAS2024-09-12
245491034722229K231898DTX Studio Clinic (4.0)LLZ2023-12-08
171281114709229K2315345008X Hemodialysis SystemKDI2024-02-02
3287761531732913K2311252008T BlueStar Hemodialysis MachineKDI2023-12-06
245491386142170K230505Orthopantomograph™ OP 3D LXOAS2023-06-09
3287761407461172K222318Fresenius Liberty Select CyclerFKX2022-10-31
171281413774632K213992CombiSet Hemodialysis Blood Tubing SetFJK2023-05-31
245491142427537K213562DTX Studio Clinic 3.0LLZ2022-03-25
245491496541727K203156DTX Studio ClinicLLZ2020-11-20
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
245491135059590K200810IPS CaseDesignerLLZ2020-10-08
245491744993311K181932DTX Studio designPNP2019-03-01
245491188954181K180947Orthopantomograph OP 3DOAS2018-06-07
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
245491137832168K172224DTX Studio diagnoseLLZ2018-01-11
245492068883119K170813ORTHOPANTOMOGRAPH OP 3DOAS2017-04-07
245491155559879K163423Orthopantomograph OP300OAS2017-08-31
245491615813220K163122NobelClinician, DTX Studio implantLLZ2017-01-31
245491685891781K162799CliniviewLLZ2017-04-25
245491899421345K161634IPS CaseDesignerLLZ2016-11-10
171281502160313K152953CRIT-LINE CLIP (CLIC) BLOOD CHAMBERKOC2015-11-05
171281832003599K141145LIBERTY PDX CYCLERFKX2014-07-30
245491078444672K133544OP300OAS2014-03-26
3287761068960956K133299ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLYKDI2014-07-07
245491675382642K133231DIGORA OPTIMEMUH2014-03-20
171282026515121K124024APD LUER-LOCK ADAPTERKDJ2013-09-19
245492033405782K122018OP300OAS2012-12-10
3088651286801815K121599CRIT-LINE CLIP (CLIC)KOC2012-11-09
171281746372367K120823BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORSFJK2012-06-15
245491221634522K093683ORTHOPANTOMOGRAPH OP300MUH2010-10-06
245492067044747K092591ORTHOPANTOMOGRAPH OP30MUH2009-11-20
171281510810106K083542FRESENIUS STERILE STAY SAFE CAPKDJ2008-12-29
245491218283058K081925SNAPSHOTMUH2008-09-02
171281683716697K070049FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTORONW2011-02-03
245491020505509K063773VOLUMETRIC TOMOGRAPHYOAS2007-01-31
245491470367817K043612ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200DEHD2005-02-09
171281528941497K043363FRESENIUS LIBERTY CYCLERFKX2005-03-31
245491712101375K041050DIGORA OPTIME (OR DIGORA ONTIME)MUH2004-06-15
171281402351667K041042SPLIT SEPTUM INJECTION SITESFPA2004-07-16
245491757987559K022630MODIFICATION TO FOCUSEHD2002-10-09
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
245491968496750K001729FOCUSEHD2000-07-13
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
245491080733616
171281727184474
171281802376684
245491827332464
1365881100685641
245491311765119
245491442737174
1365881571637094
171281626613194

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDJ102025-04-03
FKX92022-10-31
OAS82024-09-12
LLZ82023-12-08
FJK62023-05-31
KOC62020-09-18
MUH62014-03-20
KDI52025-06-13
EHD32005-02-09
MYN12025-11-17
PNP12019-03-01
ONW12011-02-03
FPA12004-07-16
FIB12000-12-01

PMN#