FDA.reportPublic FDA data

HOME HEALTH US INCORPORATED

Matched from indexed company URL: Home Health

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30211862263021186226HOME HEALTH US INCORPORATED1Y2026-01-017672 15th St E Sarasota FL US 34243
20831882083188Home Healthcare 2000 Inc., dba Tuffcare1Y2020-04-251290 SW 30TH AVE. Pompano Beach FL US 33069
30050290063005029006Home Healthcare 2000 Inc., dba Tuffcare1Y2020-04-25ROAD No. 1 -KM 26.0 BO. QUEBRADA ARENAS Alt De Caguas PR US 00725
30067981153006798115Home Health (UK) Ltd.1N2020-04-25Unit A, Greatham Road Industrial Estate, Greatham Road Bushey Hertfordshire GB WD23 2NZ

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
725511590201108K790282ELDONCARDKSZ1979-05-04
2991461795170910K790282ELDONCARDKSZ1979-05-04
2991461690106966K242721Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)DXN2024-10-04
2991461345065484K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG2024-05-10
2991461365275109K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test MidstreamLCX2024-06-21
2991461757803921K230043Insulin Pen NeedleFMI2023-09-20
2991461444682337K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceQRL2022-11-30
2991461893439055K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)DKZ2019-03-27
2991461753800922K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerFLL2018-10-29
2991461130226188K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsJIL2018-05-23
725511242672434K123050EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)LCX2013-02-05
725511033488600K112870
2991461912782242K110309FOB ONE STEP RAPID TESTKHE2011-09-14
725511499084822K100398SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEMNBW2010-06-09
725511230388167K062703ONE STEP HCG PREGNANCY TESTLCX2007-07-23
725511490817745K053033ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000DJC2006-06-06
725511604053989K053032ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000DKZ2006-02-09
725511014196293K052662ONE STEP FSH MENOPAUSAL TESTCGJ2005-11-30
725511783747565K052197FIRST SIGN DRUG OF ABUSE URINE SCREENING TESTDJR2006-06-09
725511108419872K032575FIRST SIGN DRUG OF ABUSE SCREENING TESTDKZ2004-05-19
725511018238495
725511491076869
725511501085309
725511626870179
725511647839305
725511701496218
725511808409284
725511956810972
2991461073585993
2991461115265582
2991461339690191
2991461378134216
2991461386756221
2991461393299226
2991461482288362
2991461528677452
2991461776824372
2991461823284693
2991461835383126
2991461887629325
2991461911893099
2991461967708170

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCX32024-06-21
DKZ32019-03-27
KSZ21979-05-04
DXN12024-10-04
DJG12024-05-10
FMI12023-09-20
QRL12022-11-30
FLL12018-10-29
JIL12018-05-23
KHE12011-09-14
NBW12010-06-09
DJR12006-06-09
DJC12006-06-06
CGJ12005-11-30

NDC#

Oxygen

Home Health Medical Equipment, Inc.

Oxygen

Oxygen

Home Healthworks Inc.

Oxygen

PMN#