FDA.reportPublic FDA data

BRAEMAR MANUFACTURING, LLC

Matched from indexed company URL: BRAEMAR CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21334091000520785BRAEMAR MANUFACTURING, LLC1N2026-01-011285 Corporate Center Dr Ste 150 EAGAN MN US 55121
30035840293003584029Braemar Manufacturing, LLC1N2026-01-013721 Valley Centre Drive, Suite 100 San Diego CA US 92130
21334091000520785BRAEMAR MANUFACTURING, LLC1N2020-04-251285 Corporate Center Dr Ste 150 EAGAN MN US 55121
30035840293003584029Braemar Manufacturing, LLC1N2020-04-253890 Murphy Canyon Rd Ste 100 SAN DIEGO CA US 92123

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
156391916759596K993618DXP1000 HOLTER RECORDERMWJ1999-11-24
156391100016311K981215PSI-TEC LIPOSUCTION ASPIRATORQPB1998-07-01
156391479430667K980392PSI-TEC ASPIRATORBTA1998-03-05
156391334011172K963725MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)DXH1997-09-10
156391853797425K943124HEARTRAKDXH1995-05-03
594381597719752K171410ePatchDSH2018-01-04
156391623704532K171410ePatchDSH2018-01-04
3221201811578586K171410ePatchDSH2018-01-04
3220991811578586K171410ePatchDSH2018-01-04
156391289762055K170565LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LQYX2017-08-01
156391541863089K153473Braemar Telemetry Patch SystemDSI2016-07-22
3220992040842727K153473Braemar Telemetry Patch SystemDSI2016-07-22
3221202040842727K153473Braemar Telemetry Patch SystemDSI2016-07-22
594382057994508K153473Braemar Telemetry Patch SystemDSI2016-07-22
156391161742247K151269ECG Mini System Continuous ECG Monitor and Arrhythmia DetectorDSI2016-01-15
156391935859504K143359CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorDSI2015-09-11
594381116284553K130294BRAEMAR CARDIOKEY HOLTER RECORDERMWJ2013-10-16
156392066784516K130294BRAEMAR CARDIOKEY HOLTER RECORDERMWJ2013-10-16
156391891559193K110499CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTORDSI2011-04-06
156391026025197K093288CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTIONQYX2010-04-08
594381245765177K093288CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTIONQYX2010-04-08
156391083069301K083535HEARTRAK SMART ECATDXH2008-12-15
156391102951539K072008BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDERDRG2007-10-03
156391105791560K071733DL900 SERIES HOLTER RECORDERMWJ2007-07-24
156391567502629K071011MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDERMWJ2007-04-27
156391134777618K050324INFPUMP INFILTRATION PUMPFRN2005-04-27
156391842640493K024323CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000MLO2003-06-30
594381938783333K024323CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000MLO2003-06-30
156391463318323
594381609057490
594381637209049
156391886461874
3220991977345306
3221201977345306
3220992020549550
3221202020549550

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSI72016-07-22
MWJ52013-10-16
DSH42018-01-04
QYX32017-08-01
DXH32008-12-15
MLO22003-06-30
DRG12007-10-03
FRN12005-04-27
QPB11998-07-01
BTA11998-03-05

PMN#

EPatch

2018-01-04

Braemar Manufacturing, LLC

GUDID#

80 records. Showing 1-40. Next