Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2248608

FEI Number

1000526834

Entity Name

CASE MEDICAL, INC.

City/State/Country

Bloomfield, NJ, US

Establishment Address

50 West St., Bloomfield, NJ 07003, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CASE MEDICAL, INC. (Owner Number: 9020860)

Owner / Operator Contact Address

50 WEST STREET, --, Bloomfield, NJ 07003, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K022978

PMA Number

N/A

All Registered 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 NOVAPLQ APC05 APCR1 BMS01 SCLH2023 SCPLQ3R DC01 SCS01BH SC04MG P03 NOVAPLQR SC04FG BSKH02 BMS07 BES003 P05 ENDOF1T234 DC04 BMS02 SCLH2024 BM01 P06 KC03 APCR2 BSKSDH3 DC02 BSKF01 QC06 NOVAPLQN MAT02 B05 NOVAPLQC SC05FG POST03 BMS04 BES171 P07 BSKSDF3 BSKSDF4 BSKF02 XC06 NOVAPLQO 9734987 MED38KIT ELEVATRAY 9733771 9733904 CA850S ELEVETRAY 9734448 9735255 9734446 9736064 ELEVLTRAY 9735231 1850080 9734692 9736084 MED40KIT 9736329 MED41KIT 9736377 115-0020 ELEVRTRAY 1850082 9734836 SCKIT8 MED39KIT 9734694 9734445 31814 ELEVBTRAY 9735218 1850090 9734903 9734693 SCKIT9 9735219 1850091 9734447 9735449 9735220 1850092 9734863 9734695 1850084 CA800S 9734442 9736382 1847CNTR ELEVCTRAY SCKIT7 115-0010 1850083 1850085 9734841 MAZ600S MED42KIT 9733769 9733770 1850081 DC02YD ST01 ENCL BM03 ENDOF2 EC02 BSKL02 APC04 RACK03 BSKQ06 FC02 ENDOQ2 SCPLQBH B02 ENDOHT2M APLRH ENCS BSKF04 MAT03 NOVAPLQP B06 SC08QG POST01 NOVAPLQBH SC03MG ENDOQ1T234 P08 ENDOF1 SC03NG SC06LG BSKQ03 FC06 STN1 ENDOQ1T456 NOVAPLQG B01 LC06 APC02 BSKQ02 BSKF06 SCPLQ3C SC04QG B04 BSKSDH4 APC03 ENDOH1 BES001 NOVAPLQB SCPLQ3O BSKH03 QC04 SC04H BMS10 SCPLQ3K BMS06 XC06W11 BSKSDQ4 BM06 IFT01 HC02 BSKH01 BES002 BM08 BSKW04 SCPLQ3P SC02MG DC00 FC04W SCKIT2BP BSKQ01 SC08HG BSKF03 MAT04 EC04 NOVAPLQK B03 DT01 BSKH04 SCFM01 BM07 P04 BSKL03 RACK02 EC04A DC00YD SCS01W P02 DC04YD NOVAPLQY HC04 SCPLQ3N APOR1 BMS05 SCKIT1WN BSKSDQ3 MT01 KC06 MC02 SC05WG ENDOQ1 BM05 EC00 HT01 SCKIT1BP SC04LG SCPLQ3G APOR2 BM04 FC02W FC04 B07 MC01 DC03YD APCR3 SCKIT2WN XC03 B08 APC09 DC0R SC06HG EC08SS ENDOH1T234 EC07 ENDOL1T234 ENCX STN2 EC05 BSKW02 SC06QG SCPLQ3Y APC01 BSKQ04 FC01 BSKF05 SCPLQ3B APER01 APSRK01 DC03 BMS08 MAT01 SCF02 SC02NG ENDOF1T456 ST03 SC06FG DC4GP EC08 LC03 ST02 ENCM INST09 EC01 BSKL04 QT01 SC04HG POST015 P01 INST06 POSTPLATE DT02 MAT042 RACK01 QC02 LC06W11 BMS12 POST02 BMS03 BES170 INST12 DC01YD SteriTite Container with MediTray Products BSKL04 BSKQ04 FC01 BM05 P01 SCFM01 SC02MG LC06W11 DC04YD BSKH01 HT01 HC04 BSKF02 DC01YD P06 BSKSDH4 DC04 DT01 NOVAPLQBH P05 EC04A SC04HG DC01 FC04 STN1 APC01 ENDOF1 DC00YD EC08 MC01 APSRK01 DC03 ENDOF1T456 LC06 SCLH2023 APC04 ENDOH1T234 SC03NG BM06 EC01 APOR2 POST03 ST02 BES170 BSKW02 EC05 ENCL IFT01 ENDOH1 ENDOQ2 B04 BSKH02 DC4GP ENDOQ1 LC03 ENCM ENDOQ1T456 BSKQ06 QC06 SCS01W B02 BSKH04 BSKSDQ3 SCF02 BSKD03 EC04 BMS05 SC06HG SCKIT2BP POST015 BM07 APOR1 APC03 FC06 BSKQ01 B05 EC00 SC06QG SCLH2024 SteriTite Sealed Container and MediTray Products DT02 RACK03 P08 BSKL03 BES003 STN2 P02 SCFM02 BSKSDQ4 BSKF01 FC04W KC03 EC02 BMS06 ST01 DC02 XC06W11 APCR2 NOVAPLQC POSTPLATE BSKL02 BES001 BSKF05 BM03 BSKD02 EC08SS ENDOF1T234 SC06FG BES002 BSKF06 BES171 SC02NG KC06 BMS07 INST12 QC02 SCKIT2WN BSKSDF3 B01 BSKH03 SC05WG FC02 BSKQ02 APCR3 BMS02 SC08QG QT01 SC08HG DC02YD SC03MG ENCX SC04LG ENDOHT2M SC05FG B03 ENCS INST06 BSKQ03 APCR1 B06 BMS01 SC04QG NOVAPLQ INST09 BSKF04 SCKIT1BP DC03YD BMS03 ST03 APLRH BSKW04 EC07 MC02 DC00 SC06LG BM04 APC02 ENDOF2 SCS01BH BM01 BMS08 POST02 ENDOQ1T234 BMS10 RACK02 P07 B07 XC06 DC0R BM08 P04 POST01 SC04MG SCPLQ3C RACK01 SCKIT1WN APC09 BMS12 QC04 BSKSDF4 B08 APER01 XC03 HC02 ENDOL1T234 P03 APC05 BSKSDH3 SC04FG FC02W BSKF03 MT01 BSKD01 BMS04 SCKIT2BP SCS01RSH SCKIT1BP SCS01B SCL02 SCL01 SteriTite Chemical Indicators 9733771 SCS01 SCKIT2WN SCS01R SCI001 SCKIT1WN SCPLQ3Y ENDOF1T234 BSKQ04 MT01 DC00 B06 BSKF06 HC04 BSKQ01 DT02 SCF02 NOVAPLQC LC06W11 QT01 SC06HG ENDOQ1T234 SCLH2023 FC01 DC04YD BSKF15LH APC03 SC05F SCPLQ3B SC06FG SC04FG ENDOQ1 APER01 B05 BSKF05 SCPLQ3R POST02 BM06 SCCC01 MAT03 NOVAPLQY SC04L POSTPLATE DC00YD DC01YD BES170 EC04A SCF01 DC02 APC02 SC04Q SC08H ENDOH1T234 RACK01 HT01 DC03 SCL02 SC05W BMS05 SC02MG APOR2 EC01 SC06QG BSKQ35LH SCS01 BSKH02 ENCX BSKSDH3 BSKQ02 BM08 SCCC02 DC0R MAT04 BSKH35LH BSKH01 HC02 BSKQ03 BSKF35LH SCKIT2BP FC04W B01 BSKH15LH KC06 SCPLQ3K BSKQ06 BM03 SCCO02 MAT02 BSKF02 SCPLQBH POST03 EC05 DT01 BES001 INST09 ENCM SC08QG QC04 NOVAPLQN SCKIT2WN NOVAPLQBH ENCS P03 EC00 B02 SCRINGV BSKSDQ3 BMS12 BSKF04 SC06FGV EC07 SC04HG NOVAPLQG BES003 BMS08 P01 SCCTD1 EC02 BMS04 SCCTS1 BMS07 P02 APCR1 BMS03 NOVAPLQP SC03MG BSKSDF4 SC04LG LC03 SCCC1T SC03M BMS02 B04 NOVAPLQR SC04F INST12 SCFM02 P04 FC04 ST02 ENDOQ2 B07 SCS01B ENDOH1 APCR2 QC06 SC02M NOVAPLQO MAT01 SC04H SC06H SC06HGV SC06QGV ST03 DC03YD NOVAPLQK 9735231 1850080 SCKIT8 9734447 1850090 MED38KIT 9734693 31814 9734695 9733904 1850083 9734841 9736377 115-0020 SCKIT7 CA800S MED41KIT 9734863 ELEVBTRAY ELEVLTRAY 9733770 9734987 9734692 9736084 9736382 9735255 1850081 9735220 9733769 9734903 9735449 1850082 9734694 9736329 9736064 1850084 9735219 9733771 9735218 CA850S ELEVETRAY 9734836 ELEVRTRAY 9734446 1850092 MED39KIT MED40KIT SCKIT9 MAZ600S MED42KIT 9734442 1847CNTR ELEVCTRAY 1850091 115-0010 9734445 ELEVATRAY 9734448 1850085 SC03NG SC08Q SCLH2024 FC02 DC01 SC02N SC06LG SCPLQ3N ENDOL1T234 RACK02 SCKIT1BP SCL01 BSKW04 BSKH03 SC06L SCQL APSRK01 BES171 ST01 SC08HG APC05 NOVAPLQ BSKQ15LH ENCL BM01 SCCO01 SCS01BH BSKSDQ4 BSKL03 SCPLQ3P SCPLQ3G DC4GP MC01 SC03N ENDOQ1T456 BSKL04 ENDOF2 BSKSDH4 DC02YD SC02NG MC02 STN2 B03 SCCO3H SC04MG SC04QG SCPLQ3C EC08SS LC06 DC04 XC06W11 APC04 XC06 KC03 BMS10 INST06 P06 FC02W BM05 APC09 IFT01 SC08HGV BSKF01 SC05WG APLRH BM07 NOVAPLQB ENDOF1 BMS06 SC05FG APOR1 EC04 BMS01 APC01 XC03 BSKW02 BSKSDF3 SCI001 SCHITCH P05 APCR3 ENDOHT2M SC08FGV MAT042 SC04M BSKH04 SC06Q SCFM01 FC06 ENDOF1T456 STN1 B08 SC06F BSKF03 P07 EC08 BM04 POST015 SC08FG BSKL02 SC08F RACK03 SCCO03 SC-RING SCS01W SCPLQ3O P08 POST01 QC02 BES002 SC08QGV DC01 B03 APOR1 NOVAPLQC BSKSDF3 BMS05 BSKSDH4 SCS01 HC04 APC03 SC06F BMS03 BSKF02 APOR2 POSTPLATE DT02 BM07 BMS08 P01 BSKF03 DC04 DT01 BM08 SCPLQBH APC04 DC01YD SC06QG B07 EC04A SC06HG SCCO3H NOVAPLQK BSKH01 BSKL03 SCS01BH MAT02 SC06Q SC03NG SC06H P03 P08 EC07 DC02 ENDOQ1T234 BSKQ03 BM05 BMS04 BES170 SC08FG IFT01 QC02 SCPLQ3G BMS10 P07 APC01 ELEVLTRAY 9734695 9733904 31814 1850085 9734447 MAZ600S 115-0020 ELEVRTRAY 9733769 ELEVETRAY MED38KIT ELEVATRAY 9734448 9734694 9733771 9735219 1850090 9734903 9736382 9734446 1850092 MED39KIT CA850S 9734445 115-0010 MED40KIT 1850082 SCKIT9 1850091 ELEVBTRAY 1847CNTR ELEVCTRAY MED41KIT 1850081 SCKIT8 1850080 SCKIT7 9734442 9735220 9735449 9736329 CA800S 9734693 9734987 9736377 9734863 9734841 9734836 9735231 9735255 9734692 9736064 1850084 9736084 1850083 9733770 9735218 MED42KIT APCR2 SC06QGV BSKF15LH SCL01 SCCC01 NOVAPLQN DC4GP SC05W DC03YD HT01 SCCTS1 SCCTD1 SC04M SC08H SC08HG SC04HG B06 NOVAPLQG BSKL02 SC04Q MT01 EC05 APC02 ENDOF1T456 BSKQ15LH SCPLQ3Y FC01 BMS06 SC04FG BES001 QT01 SCLH2024 FC04 BSKH04 XC06 SCFM02 MC02 SCCC1T ENCX RACK01 BSKH03 APSRK01 SC08Q EC02 SCKIT2BP SC02NG NOVAPLQR ST02 SC05F MAT04 SC06L SCKIT2WN P04 SC06FGV STN2 B02 QC04 HC02 BSKQ06 SC-RING SC04MG BMS02 SCPLQ3P INST06 BSKF06 B05 SCHITCH NOVAPLQY SC03M SC08FGV B08 MAT03 SCS01W P02 XC06W11 SC08HGV ENDOF1 BMS01 P06 EC08 BES002 BSKH35LH SCL02 BSKSDQ4 QC06 FC04W BMS12 EC04 BSKQ35LH SC06HGV SC02N SCPLQ3N ENDOH1T234 SCS01B APCR1 APLRH DC00YD SC02MG FC02 APER01 STN1 ENDOQ1 APCR3 BSKQ02 INST09 SCF02 BSKF04 BSKW02 SCCO01 ENDOL1T234 ST01 BM03 SCQL EC00 DC0R SCI001 LC06W11 ENDOQ2 SC03MG FC06 DC04YD BSKSDH3 LC06 SC08QG SCCO02 NOVAPLQP SC08QGV SCPLQ3C BM04 BSKH15LH P05 NOVAPLQ BSKF05 SC04LG NOVAPLQO SC04QG SCPLQ3B BM01 SCRINGV EC01 POST01 ENCS ENDOF1T234 SCCC02 SCPLQ3K RACK02 BES171 SCF01 BES003 DC02YD BSKSDQ3 BSKL04 SC04H BSKH02 ENDOF2 SCFM01 MC01 NOVAPLQBH KC06 RACK03 SCKIT1WN SC08F LC03 BSKF01 DC03 SC02M SC03N ENDOHT2M MAT01 POST015 APC05 POST03 ENCL BSKW04 SCLH2023 BSKQ01 SC04F BSKSDF4 INST12 SC06FG POST02 KC03 BSKF35LH EC08SS SC05WG BSKQ04 SC05FG BM06 XC03 DC00 SC06LG SCCO03 SCPLQ3R SC04L ENDOH1 B04 ENDOQ1T456 MAT042 FC02W SCPLQ3O SCKIT1BP B01 ENCM NOVAPLQB ST03 BMS07 APC09 SteriTite container system and MediTray products for AMSCO V-PRO1Plus and AMSCO V-PRO maX APSRK01 STN1 POSTPLATE BMS04 APER01 APLRH BSKF02 SCL01 NOVAPLQK BSKSDF4 INST06 RACK01 ENCL ST02 BMS03 QC04 BSKSDH3 RACK02 ENDOL1T234 SCS01BH ENDOH1 APOR1 LC06W11 SCS01W BM03 EC08 MAT01 KC03 SCPLQBH POST015 P03 APCR3 BSKF06 BSKF35LH SC08FGV NOVAPLQB SC-RING APCR1 XC06 B04 BSKH35LH ENDOQ2 HC02 P01 FC02 SC06QGV BSKH02 ST01 EC05 MAT02 QT01 B07 BSKH01 SC06HGV FC02W BSKF15LH DT02 BSKL02 FC04W MAT03 BM06 NOVAPLQP ENDOH1T234 APC01 DC03 ENDOF1T456 SCPLQ3P DC4GP NOVAPLQO DC04YD EC00 NOVAPLQ APC05 SCKIT1BP SCPLQ3K BSKH03 BM07 ENDOF2 APC02 B02 APC03 DC02YD DC01 SCPLQ3G SC08QGV BES003 DC03YD SCPLQ3O EC08SS P08 QC06 B01 APC04 BSKQ04 BSKSDQ3 BMS10 P04 FC01 BSKQ35LH POST02 APOR2 BSKQ06 SCPLQ3R NOVAPLQG LC06 DC0R EC04A BMS01 FC06 ENCS ENDOQ1T234 QC02 BMS06 BES170 SCKIT2BP POST01 SC06FGV HC04 BM04 DC00YD BSKSDF3 APC09 ENCM BSKQ01 BES171 SteriTite Container System Flash 9734863 MAZ600S MED42KIT 9733769 9734987 9736377 ELEVBTRAY 9735220 1850092 MED39KIT 9735255 SCKIT8 9735449 SCKIT9 9736084 MED40KIT 9734448 1850082 9734836 9734446 1850083 9733771 9735219 1850091 115-0010 9736064 ELEVLTRAY 1847CNTR ELEVCTRAY 9734695 CA850S ELEVETRAY 9734447 1850084 115-0020 ELEVRTRAY 9735231 1850080 SCKIT7 ELEVATRAY 9734694 CA800S 9734692 9734693 1850085 9733904 9733770 9735218 1850090 MED38KIT 9734445 1850081 9734442 31814 9736329 MED41KIT 9734841 9734903 9736382 NOVAPLQBH STN2 BSKH04 NOVAPLQR BMS05 MAT04 B05 BSKF05 ENDOF1T234 SCPLQ3C BM08 SCS01 EC04 ENCX MC02 BMS07 P05 B08 SCI001 XC06W11 SCKIT1WN BMS12 ENDOF1 DT01 BSKF03 BSKW02 SC08HGV NOVAPLQY EC01 INST12 KC06 SCS01B SCRINGV EC02 XC03 BSKH15LH MAT042 BMS02 HT01 DC00 DC01YD BSKQ03 DC04 P07 LC03 BSKQ15LH BSKF04 SCPLQ3N BSKL04 NOVAPLQN INST09 BSKSDH4 ENDOQ1 BSKSDQ4 P02 FC04 POST03 BSKQ02 IFT01 BSKW04 MC01 BM05 BMS08 P06 DC02 BES002 ENDOHT2M SCPLQ3Y MT01 SCKIT2WN B06 ENDOQ1T456 RACK03 BSKL03 SCPLQ3B NOVAPLQC ST03 APCR2 B03 BES001 BSKF01 SCL02 BM01 EC07

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2011-01-13
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2007-11-27
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2022-09-19
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2011-10-21
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2007-11-27
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2008-12-11
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2007-11-27
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2015-12-03
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2007-11-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CASE MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2248608. Last updated year: 2026. Please use registration number 2248608 when referencing this establishment in official correspondence.