FDA.reportPublic FDA data

FLEXICARE MEDICAL LTD.

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

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
407032009467400K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)EOQ2026-09-02
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
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
407031071559551
407031155903734
407031177203395
407031184509634
407031191024341
407031196871350
407031249570073
407031265419542
407031269507925
407031304930620
407031312769450
407031338382679
407031344569086
407031387504421
407031389987104
407031393056748
407031482049326
407031505252205
407031607767918
407031619494537
407031657259683
407031685984742
407031686586437
407031724185529
407031759723730
407031760290919
407031821997991
407031830571659
407031837909061
407031844015003
407031929038833
407031932354531
407031947512782
407031980468638
407032038780574
407032055883989
407032061919999

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAH62020-03-23
BTT42026-01-16
CCK32014-04-30
BTR22025-05-20
BTM22018-12-07
BZE22016-06-23
EOQ12026-09-02
CAP12020-11-13
FPL12013-05-23
CAF12011-07-01
BYE12011-04-20

PMN#