CASE MEDICAL, INC.

Registration Details

Registration Name: CASE MEDICAL, INC.
Registration Number: 2248608
FEI Number: 1000526834
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 50 West St.
City: Bloomfield
State: NJ
ZIP: 07003
Country: US

Regulatory Submissions

510(k) Number: K090068

Owner / Operator

Firm Name: CASE MEDICAL, INC.
Operator Number: 9020860
Address: 50 WEST STREET, --
City: Bloomfield
State: NJ
Postal Code: 07003
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Wrap, Sterilization	FRG	Class 2	General Hospital	No	2011-01-13
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	Class 2	General Hospital	No	2022-09-19
Indicator, Physical/Chemical Sterilization Process	JOJ	Class 2	General Hospital	No	2007-11-27

Proprietary Names

SC04QG DT02 BMS12 BM07 BM04 EC08SS BSKF04 APC02 BES171 BMS03 ENDOQ1T456 APC09 INST06 HC04 P03 BSKL04 BSKF01 BM08 SC04FG BMS07 SCPLQ3 EC04 B07 BSKSDF3 BM06 NOVAPLQN FC04W SCKIT1WN APC03 ENDOF1T234 BMS02 APC04 FC04 BMS01 QC02 B01 DC00 SCPLQBH NOVAPLQBH SC06FG BSKSDQ3 B08 DC04 NOVAPLQR APCR2 BMS06 P01 B03 SCS01BH ENDOH1 FC02W FC01 APLRH EC08 XC03 MT01 DC02 NOVAPLQK SC05FG EC01 BSKH02 NOVAPLQG SC06HG P07 ENDOH1T234 B06 SCLH2023 BSKQ04 RACK01 ENCL P02 SC02NG B05 BSKSDF4 LC03 BM05 RACK02 ENCM DT01 APOR2 BM03 SCKIT1BP SC08HG SC03NG STN2 ENDOQ1T234 BM01 SC08FG P04 B04 SCLH2024 BSKF05 NOVAPLQY ENCS XC06W11 ENDOL1T234 SC04MG ENDOF2 NOVAPLQB BES003 SteriTite Container System 9733771 1850091 115-0020 9734863 9734841 9734447 MED39KIT 9734692 9734448 9735255 SCKIT8 9734693 9734695 9735218 1850090 ELEVATRAY 9736064 ELEVLTRAY 1850082 1850080 115-0010 9734694 9734442 9735219 9733770 1850084 9734836 9735220 9734446 9734445 9735231 SCKIT7 9733769 9736084 1850083 MED40KIT 9733904 CA850S ELEVETRAY MED38KIT 9734987 9736377 ELEVRTRAY 1850081 31814 1850085 1850092 ELEVBTRAY 9736329 CA800S MED41KIT 9734903 9736382 MAZ600S MED42KIT 1847CNTR ELEVCTRAY 9735449 SCKIT9 SCKIT2WN APC05 ENDOF1 FC02 LC06W11 QC06 BSKL03 DC0R LC06 APC01 SCS01W SC05WG POSTPLATE IFT01 STN1 KC06 SC08QG SC06LG BES002 B02 BSKF02 RACK03 APER01 ENCX SC06QG HT01 ST02 ENDOQ2 ENDOHT2M DC03YD ST01 ENDOQ1 HC02 BSKL02 EC07 BMS10 BSKQ06 BES001 EC00 BSKH03 SC04HG P06 SC04LG APSRK01 SCKIT2BP NOVAPLQP APCR1 BMS05 EC05 APOR1 BSKQ03 NOVAPLQO DC01YD ENDOF1T456 BSKSDH4 EC02 POST01 EC04A P05 DC04YD KC03 QT01 INST09 SC02MG DC02YD DC4GP BSKH01 NOVAPLQC BSKW02 P08 NOVAPLQ BSKF03 MC01 APCR3 FC06 BMS08 BSKSDQ4 XC06 DC03 POST03 BSKW04 INST12 SCFM02 BSKSDH3 MC02 BSKQ01 BSKF06 QC04 DC01 POST02 BES170 BMS04 SC03MG BSKH04 SCF02 BSKQ02 POST015 DC00YD SCPLQ3R MAT02 MAT03 SCPLQ3C SCPLQ3O SC04H SCPLQ3K SCPLQ3P MAT04 SCFM01 SCPLQ3N SCPLQ3G SCPLQ3Y SCPLQ3B MAT01 ST03 MAT042 SteriTite Container with MediTray Products BSKD03 SteriTite Sealed Container and MediTray Products BSKD02 BSKD01 SCS01RSH SCS01B SCL02 SCL01 SteriTite Chemical Indicators SCS01 SCS01R SCI001 BSKF15LH SC05F SCCC01 SC04L SCF01 SC04Q SC08H SC05W BSKQ35LH SCCC02 BSKH35LH BSKF35LH BSKH15LH SCCO02 SCRINGV SC06FGV SCCTD1 SCCTS1 SCCC1T SC03M SC04F SC02M SC06H SC06HGV SC06QGV SC08Q SC02N SC06L SCQL BSKQ15LH SCCO01 SC03N SCCO3H SC08HGV SCHITCH SC08FGV SC04M SC06Q SC06F SC08F SCCO03 SC-RING SC08QGV SteriTite container system and MediTray products for AMSCO V-PRO1Plus and AMSCO V-PRO maX SteriTite Container System Flash 9736659 9736661 9736657 9736655 KSZ-SCLL KSZ-SCHL KSZ-STCRDSM 9736478 CSP011 CSNCD1W CSI002 CSCCC24 KSZ-39301SR HCI03 ARTHROTRAY1 KSZ-39311AS BOS02C05 CSR012 BOS02T07 BOS11T BOS14T KSZ-39302 KSZ-STSEAL BOS02T09 9736524 CSL014 KSZ-39301C1S BOS02C07 ITX015 CCW001 9736526 KSZ-39301AS KSZ-39312SV IQT01 BOS02C06 BOS15 BOS01R DPY-SCF01 BES004 BOS18 CSA015 CSNB01G KSZ-39301SP BOS01S BSKQ05 KSZ-SC08LGC KSZ-39301CS IFT02 9736531 DC00Y BOS02C02 KSZ-39312J KSZ-SC03NGC CSC011 AK01 CSNB01GW CSNB25GW B05K BOS02C03 FCL2 BOS01R03M CSNC01W KSZ-STRCTFLTR KSZ-39406AS-RKT BOS01S04M KSZ-39312GSI BOS01T ARTHROTRAY2 KSZ-SC08FGC CSI003 DPY-SCFM02 KSZ-LTCRDLG KSZ-39403AS BOS13T CSSTR02 9736276 KSZ-39316F KSZ-27717D CSNC25GW FCI03 CSNB25G CSNL01G CSNC01GW CSP015 CSSTR24 CSNC25G B02K KSZ-39301TS KSZ-39402AS-RKT KSZ-39402AS KSZ-39312M CCW003 BOS16 CSWA002 CSNB01W KSZ-SC05FGC KSZ-39301LTA CSP02 BOS12T KSZ-39301HCTS BOS04 BOS10T 9736471 KSZ-SCKIT4 BOS02 BOS01 KSZ-LTRCTFLTR BOS02T08 KSZ-STRNDFLTR CSSTR011W KSZ-SC04FGC BOS01S03M KSZ-39312SB KSZ-LTSEAL CSNL01W CSNB252 BOS02C04 KSZ-SCKIT1 9736525 CSP012 KSZ-STSTRIP KSZ-39406AS 9736663 9736660 IHT01 KSZ-SC04LGC KSZ-SCKIT3 KSZ-39403AS-RKT BOS02T06 CSA012 9736534 9736479 BOS02MOD ENDOL1 KSZ-39301BS KSZ-39312FESS BOS02T01 CMAX100 9736529 KSZ-39314FS KSZ-39312VMS B03K CSEKIT12 KSZ-SC06LGC KSZ-27717DS B01K 9736523 KSZ-SC03MGC KSZ-STCRDLG 9736651 9736652 B08K BOS04M KSZ-SC04HGC KSZ-SCKIT2 CSNC25W 9736530 BOS17 CSI001 CSNC01G 9736527 BOS01R06M CCW004 CSA011 KSZ-SCQL 9736654 KSZ-SCQL2 9736633 9736656 KSZ-LTCRDSM BOS04B KSZ-SC08QGC KSZ-39312D KSZ-LTRNDFLTR CSR011 KSZ-SCML2 CMAX100SS CSNC252 BOS01R07M KSZ-SC04QGC BOS09T ENDOL1T456 CSWE03 9736528 BOS02T CSNB25W CSSTR016W KSZ-SCFL APPW2 BSKH05 CSWE002 KSZ-39312C BOS04T IMT01 CSC002 FC35RTC KSZ-39301CMAC BSKL01 BOS01S05M CSNL01GW CSL02 CSC008 9736662 9736632 9736653 Steritite container system STERRAD SC05QG ME02KIT NPC055 KSZ-SCKIT2BP NPB055 PAL02 ME06KIT KSZ-SCF02 ME01KIT ME05KIT SCO3NLG KSZ-SCFM01 NUVSC04 ME03 KSZ-SCKIT2WN MED43KIT NTI02 SC08LG KSZ-SCLH2O24 KSZ-SCKIT1WN ME05 NTI-SCF02 ME06SC P12 SCS01SH NPL055 MED44KIT 9734443 NTI-SCLH2O23 KSZ-SCS01B SCO4NL SC05NL NPIBK2 SC05Q P09 NUVSC01 NTI-SCL01 STCN2 SC05NLG NTI-SCS01B WCI03 9734444 NPA024 KSZ-SCS01R KSZ-SCL01 ME04 SC04NLG ME05SC NUVSC03 SQ002 NPP024 ME03KIT NPC100 KSZ-39321 QCI03 KSZ-39322 P13 NPIBK1 KSZ-SCLH2O23 P11 NPD055 STX01 ME04SC KSZ-SCFM02 ME03SC LCI03 NTI01 STCM2 NTI-SCS01W SC08L P10 MED45KIT ME04KIT KSZ-SCL02 SCS01RP KSZ-SCF01 NPEKIT1 SCO3NL NUVSC02 KSZ-SCKIT1BP NPIBK3 SQ001 SteriTite sealed container and MediTray accessories SteriTite container system prevac

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198