FDA.reportPublic FDA data

SUNMED AP, LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30059984973005998497SUNMED AP, LTD.1N2026-01-016-9 ZHUFENG RD., QIANNAN INDUSTRIAL PARK QIANWU TOWN, DOUMEN DISTRICT ZHUHAI Guangdong CN 519170

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
367671366552825K990098VENTLAB VERIFY IIBTR1999-02-11
367671349289676K982215MANUAL RESUSCITATOR WITH ACEBTM1998-09-18
367671430828373K981944BREATHERITECAF1998-08-24
367671657756892K961867PEEP VALVEBYE1996-08-13
367671857989945K953546MANUAL PULMONARY RESUSICITATORBTM1996-02-29
367671418995218K953107ANESTHESIA/RESPIRATORY FACE MASKBSJ1995-08-15
367671494474919K173373SafeT T-Piece ResuscitatorBTL2018-11-16
367671495923626K130598INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBERNVP2013-06-05
367671795395949K120118VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETERCAP2012-05-24
367671488048909K102674CUFF SENTRYBSK2011-07-22
367672066013517K093617VENTLAB 6000 SERIES HUMIDIFIERBTT2011-01-27
367671194350434K093525ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHECCK2009-12-10
367671007187632K090840VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.CAF2009-06-25
367671255166943K063813VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULACCK2008-03-26
367671328035408K030271VENTLAB BACTERIAL FILTER, MODEL BF100CAH2003-07-07
367671727510549K020281MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEMNHK2002-02-11
367671965801086K012842V*CARE MANUAL RESUSCITATORBTM2001-09-18
367671219427316
367671247160751
367671410094126
367671536880308
367671626841101
367671634904868
367671773880473
367671906629546
367671964863911
367671194350434
367671198197364
367671255166943
367671328035408
367671400022390
367671418995218
367671430828373
367671494474919
367671577678310
367671657756892
367671689958802
367671727510549
367671824396972
367671910510201
367671957679614

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BTM32001-09-18
CCK22009-12-10
CAF22009-06-25
BTL12018-11-16
NVP12013-06-05
CAP12012-05-24
BSK12011-07-22
BTT12011-01-27
CAH12003-07-07
NHK12002-02-11
BTR11999-02-11
BYE11996-08-13
BSJ11995-08-15