FDA.reportPublic FDA data

ResMed Asia Pte. Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30073276003007327600ResMed Asia Pte. Ltd.1N2020-04-258 Loyang Crescent No. 05 - 01 Singapore Not Applicable SG 509016

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
09353645000081Carry Case Activox - Carry Case, Universal, Activox800-427-0737reception@resmed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
944582056652443K183512Moore Park MaskBZD2019-05-07
944581138158284K180497Scone MaskBZD2018-06-15
944582049858372K171212AirFit N20BZD2017-09-28
944581033221944K170924AirFit F20BZD2018-01-03
944581397150670K161978AirFit N20BZD2016-11-17
944581177362491K153673AirFit N20BZD2016-05-02
944581519521336K153563AirFit F20BZD2016-05-13
944582061228260K153061Juno VPAP ST-AMNS2016-04-13
944581873397802K140279S9 GREENHILLSBZD2014-07-31
944581591373970K140159S9 WANDA VPAP STBZD2014-06-17
944581439023676K140124S9 ELOUERABZD2014-05-12
944581450117624K132887AIRFIT N10BZD2013-12-20
944581521652490K132205ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEMCAW2014-06-06
944581841125675K132013SWIFT AIRBZD2013-10-21
944581102885368K123979QUATTRO AIRBZD2013-02-27
944581374094236K123789SWIFT FX NANOBZD2013-03-29
944581751314334K113317LIFECHOICE OXYGEN CONCENTRATORCAW2011-12-28
944581569142828K112489SWIFT FX BELLABZD2011-12-07
944581288363342K102746MIRAGE FXBZD2010-12-28
944581895672128K102513S9 VPAP ST WITH H5IBZD2011-01-05
944581520855923K091947S8 ASPEN WITH H4I PLUSBZD2009-09-28
944581870115846K091129QUATTRO LTBZD2009-08-03
944581669564388K090244SWIFT FXBZD2009-04-13
944581543181528K073638SWIFT LTBZD2008-03-20
944582049252080K072688LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000CAW2008-01-11
944581530176126K063122MIRAGE QUATTRO FULL FACE MASKBZD2007-02-02
944581801191435K063011MIRAGE LIBERTY FULL FACE MASKBZD2007-02-02
944581336250306K050359ULTRA MIRAGE II MASKBZD2005-03-16
944581745819187K042403MIRAGE SWIFTBZD2004-10-08
944581245881609K023306MIRAGE FULL FACE MASK SERIES 2BZD2002-11-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZD262019-05-07
CAW32014-06-06
MNS12016-04-13

GUDID#