FDA.reportPublic FDA data

Brian Szeremeta

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30040484943004048494Brian Szeremeta1N2026-01-01Coopersurgical Inc. 95 Corporate Dr Trumbull CT US 06611
30142958583014295858Brian Szeremeta1N2026-01-0195 Corporate Drive, TRUMBULL, CONNECTICUT, 06611, UNITED STATES Trumbull CT US 06611
30147553763014755376Brian Szeremeta1N2026-01-0195 Corporate Drive, TRUMBULL, CONNECTICUT, 06611, UNITED STATES Trumbull CT US 06611

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2498631388474690K991470MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060)MQL2000-03-07
154151502361524K991470MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060)MQL2000-03-07
154151529973785K991395QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUMMQL2000-02-15
154151649516348K991393HYALURONIDASE, 80 U/MLMQL2000-02-02
154151432020149K991392HUMAN SERUM ALBUMINMQL2000-02-07
154151662761873K991391PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTFMQL2000-01-10
154151552523066K9913901.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDIMQL2000-01-18
154151946023328K991381PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSAMQL1999-09-24
154152024192842K991380OIL FOR TISSUE CULTUREMQL2000-04-19
154151921547381K991379QUINN'S SPERM WASHING MEDIUMMQL2000-02-02
154151877457865K991378PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL REDMQL1999-09-24
154151559879012K991335MEDI-CULT FREEZING & THAWING PACKSMQL2000-02-28
2498631827598012K991335MEDI-CULT FREEZING & THAWING PACKSMQL2000-02-28
154151699897060K991333MEDI-CULT SPERM FREEZE MEDIUMMQL2000-02-28
2498631841682120K991333MEDI-CULT SPERM FREEZE MEDIUMMQL2000-02-28
154151128360548K991332MEDI-CULT SPERM PREPARATION - MEDIUM;MQL2000-05-04
2498631874446235K991332MEDI-CULT SPERM PREPARATION - MEDIUM;MQL2000-05-04
2498631305370729K991330MEDI-CULT LIQUID PARAFFINMQL2000-02-25
154151500618544K991330MEDI-CULT LIQUID PARAFFINMQL2000-02-25
154151260657821K991329MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADEMQL2000-02-25
2498631555989647K991329MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADEMQL2000-02-25
154151485748859K991327MEDI-CULT FLUSHING MEDIUMMQL2000-05-04
2498631647862053K991327MEDI-CULT FLUSHING MEDIUMMQL2000-05-04
154151176203381K991279MEDI-CULT UNIVERSAL IVF-MEDIUMMQL2000-07-20
2498631492135396K991279MEDI-CULT UNIVERSAL IVF-MEDIUMMQL2000-07-20
2498631449484786K991173<GENX> FERTILIZATION MEDIA-HTFMQL1999-07-19
2362122024309162K990847INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING MMQH1999-07-14
2362121018094535K990350WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316MQF1999-07-26
2498631018094535K990350WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316MQF1999-07-26
2362121397807667K990349WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NSTMQF1999-07-26
2498631397807667K990349WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NSTMQF1999-07-26
2362121530112690K990348WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816NMQF1999-07-26
2498631530112690K990348WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816NMQF1999-07-26
2498631589545747K964848WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CMMFD1997-01-16
2498631273985328K934011MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASEHDB1994-05-04
154151264083898K200680Synvitro HyadaseMQL2020-07-17
2362121371927651K191291Wallace Dual Lumen Oocyte Recovery SystemMQE2019-06-12
2498631371927651K191291Wallace Dual Lumen Oocyte Recovery SystemMQE2019-06-12
2362121879118268K182959Wallace Dual Lumen Oocyte Recovery SystemMQE2019-05-10
2498631879118268K182959Wallace Dual Lumen Oocyte Recovery SystemMQE2019-05-10
154152038374335K180740VitriGuardMQK2018-05-04
154151461790506K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)MQL2018-03-02
2498631312944909K173624ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)MQL2018-03-02
154151325699597K173624ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)MQL2018-03-02
154151974856752K172197SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPSMQL2017-10-13
2498632041598685K172197SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPSMQL2017-10-13
154151377300915K170560SAGE Vitrification Kit and SAGE Vitrification Warming KitMQL2017-04-04
154151216590067K162833VitriGuardMQK2017-02-16
154151817674031K161547Transem and EchoGen Embryo Transfer CathetersMQF2017-03-09
154151635213995K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashMQL2016-07-22
2498632067522715K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashMQL2016-07-22
154151100128880K152932BlastGenMQL2016-02-29
2498631505564053K152932BlastGenMQL2016-02-29
2498631513538991K143498LifeGlobal Global HPMQL2015-01-20
2498631922260365K142991LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSAMQL2015-02-17
2498631823104233K140317EMBRYOGENMQL2014-06-16
154151907762421K140317EMBRYOGENMQL2014-06-16
154151701892490K133912ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIOMQL2014-05-14
2498631820814028K133912ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIOMQL2014-05-14
2498631186875220K133707SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTSMQL2014-04-16
154151489350969K133707SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTSMQL2014-04-16
2498631337976435K133387ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL REDMQL2014-04-29
154151573904718K133387ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL REDMQL2014-04-29
154151535598120K120136EMBRYOGENMQL2012-09-26
2498631560238379K112083LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPESMQL2012-05-03
154151527589335K100367MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229MQL2010-08-27
2498631434411228K092963GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3MQL2011-01-14
2498631505359837K092667GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KITMQL2010-06-03
2498632019430483K092578LIFEGLOBAL PROTEIN SUPPLEMENTMQL2010-04-05
154151216654644K081639ICSI CUMULASEMQL2008-09-19
2498631697214396K081639ICSI CUMULASEMQL2008-09-19
154151122835404K080473EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL REDMQL2008-09-03
154152034361291K080172BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216MQL2008-12-18
154151621144153K073522VITRIFICATION KIT & VITRIFICATION WARMING KITMQL2008-10-10
2498631316182287K061145SPERMSLOWMQL2006-10-02
154151489526026K061145SPERMSLOWMQL2006-10-02
154151000053076K060983BIOPSY MEDIUM, MODEL REF 1062MQL2006-07-28
2498631646365718K060983BIOPSY MEDIUM, MODEL REF 1062MQL2006-07-28
154151553011332K053646INVITRO MATURATION MEDIAMQL2006-07-14
2498631295675117K053552GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIAMQL2006-05-19
154151205472258K041284MEDICULT IVM SYSTEMMQL2004-11-22
2498631813094086K041284MEDICULT IVM SYSTEMMQL2004-11-22
2498631543661495K040530MEDIA CULTURE SYSTEMMQL2004-06-25
2362121503971291K033084WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETERMQF2003-12-19
2498631503971291K033084WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETERMQF2003-12-19
154151537410228K031486BLASTFREEZE AND BLASTTHAWMQL2003-06-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQL1172020-07-17
MQF92017-03-09
MQE82019-06-12
MQK42018-05-04
MQH32002-02-11
MQG12003-08-27
HHW12002-02-11
MFD11997-01-16
HDB11994-05-04