FDA.reportPublic FDA data

FLEXICARE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80219953006363476FLEXICARE MEDICAL LTD.1N2026-01-01CYNON VALLEY BUSINESS PARK MOUNTAIN ASH RHONDDA CYNON TAFF Wales GB CF45 4ER
30059192573005919257FLEXICARE INC.1Y2026-01-0125671 Commercentre Drive Lake Forest CA US 92630
30060617493006061749FLEXICARE MEDICAL (DONGGUAN) LTD.1N2026-01-01No. B-15 XICHENG INDUSTRIAL ZONE HENGLI TOWN, DONGGUAN CITY Guangdong CN 523460

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
407031669642441K983817BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)CAH1999-03-01
407031957244374K251448FL-10000U Respiratory HumidifierBTT2026-01-16
407031548043690K250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)BTR2025-05-20
407032000634261K201666SINGLE USE MANOMETERCAP2020-11-13
407031865650560K191909HepaShield Bacterial Viral Breathing System FilterCAH2020-03-23
407031810262903K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20BTM2018-12-07
407031114267281K163300ThermoShield HME FilterCAH2017-03-22
407031496146544K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASEBTT2016-07-06
407041496146544K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASEBTT2016-07-06
407032014749644K160540FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEMBZE2016-06-23
407031828518512K150900Flexicare Heated Wire Breathing SystemsBZE2015-05-15
407031508125075K140473DUALGUARDCCK2014-04-10
407031261328631K140113O2 NASAL CANNULA WITH CO2 MONITORINGCCK2014-03-06
407031398043422K133516CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTERCCK2014-04-30
407031565878712K123937ATOM TRANSCAPSULE V-707FPL2013-05-23
407031320379968K122885MEDISIZE GOLD HEATER AND BOOSTER T-PIECEBTT2013-08-29
407031054341565K110246MEDISIZE RED AND MEDISIZE BLUECAH2011-11-04
407031452471947K103833NEOPIP PATIENT CIRCUIT WITH PEEPBYE2011-04-20
407031606918310K102719ATLANTEAN TRIGGER NEBULIZERCAF2011-07-01
407031727132260K092218FLEXICARE BREATHING FILTERSCAH2009-10-06
407031505215542K091591FLEXICARE MEDICAL ENDOTRACHEAL TUBESBTR2009-06-17
407032070809112K081536MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE REDCAH2009-01-23
407031322669135K072021NEOPIP INFANT RESUSCITATORBTM2007-09-12
407031766482868K052615MEDISIZE GOLDBTT2005-12-09
407031005083990
407041005083990
407041054341565
407031071559551
407041071559551
407041114267281
407031155903734
407041155903734
407041159619746
407031177203395
407041177203395
407031184509634
407041184509634
407031191024341
407041191024341
407031196871350
407041196871350
407031249570073
407041261328631
407031265419542
407041265419542
407031269507925
407041269507925
407031304930620
407041304930620
407031312769450
407041312769450
407041320379968
407041322669135
407031338382679
407041338382679
407031344569086
407041344569086
407031387504421
407041387504421
407031393056748
407041393056748
407041398043422
407041452471947
407031482049326
407041482049326
407041505215542
407031505252205
407041505252205
407041508125075
407041548043690
407041606918310
407031607767918
407041607767918
407031619494537
407031657259683
407041657259683
407041669642441
407031685984742
407041685984742
407031686586437
407041686586437
407031724185529
407041724185529
407041727132260
407031759723730
407041759723730
407031760290919
407041760290919
407041766482868
407041810262903
407031821997991
407041821997991
407041828518512
407031830571659
407041830571659
407031837909061
407041837909061
407031844015003
407041844015003
407041865650560
407031929038833
407041929038833
407031932354531
407041932354531
407031947512782
407041947512782
407041957244374
407031980468638
407041980468638
407042000634261
407042000760424
407042014749644
407032038780574
407042038780574
407032055883989
407042055883989
407032061919999
407042061919999
407042070809112

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAH62020-03-23
BTT52026-01-16
CCK32014-04-30
BTR22025-05-20
BTM22018-12-07
BZE22016-06-23
CAP12020-11-13
FPL12013-05-23
CAF12011-07-01
BYE12011-04-20

PMN#

GUDID#

80 records. Showing 1-40. Next