FDA.reportPublic FDA data

DRAEGER MEDICAL SYSTEMS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25109542510954DRAEGER MEDICAL SYSTEMS, INC.1N2026-01-013135 QUARRY RD. Telford PA US 18969
30057834253005783425DRAEGER MEDICAL SYSTEMS, INC.1N2026-01-016 TECH DRIVE ANDOVER MA US 01810

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
04049098000406Breathing hose for Resuscitaire with AutoBreath, disposable, 25 pcs. - MU10841+18004372437info@draeger.com
04049098053785Infinity etCO2 SmartPod - 5740720+18004372437info@draeger.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
647261451217962K991884SIEMENS FIO2 SENSORCCL1999-11-03
647261006235521K991012SIEMENS INFINITY EEG PODOLT1999-06-24
647261826177765K980287SIEMENS SC9000/SC9015 TCP02/C02 MODULEKLK1998-08-12
647251107555391K960980ISOLETTE INFANT INCUBATORFMZ1996-07-30
647261763549429K954632SIEMENS SC 9000 ETCO2 MODULECCK1996-02-05
647251037976987K941106MODEL TI500 ISOLETTE INFANT INCUBATORFPL1994-06-10
647251233275704K940975C450/C400 INFANT INCUBATORSFMZ1994-06-23
647251808397874K940951RW RESUCITAIRE INFANT RADIANT WARMERFMT1995-05-03
647251501421038K912908AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEMLBI1991-12-13
647251059304309K875270INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUSFMT1988-01-19
647251197879778K872742WARM WEIGH MODELS I-20/W-30 INFANT SCALEFMT1987-10-20
647251202140592K840454PHOTOTHERAPY UNIT 7850 NEONATAL PHOTOLBI1984-03-23
647252030736439K810953MODEL 533 PHOTOTHERAPY UNITLBI1981-04-23
647251176195398K810474PROBE COVERFLL1981-03-31
647261687501502K260579Infinity® Acute Care System (IACS) – VG8.1MHX2026-08-20
647251997021696K243606Babyroo TN300FMT2025-01-17
647261194330787K240312Infinity CentralStation WideMHX2024-08-01
647261968438326K233834Infinity Gateway SuiteMSX2024-07-12
647261503551261K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+MHX2023-10-17
647251411449550K230278Babyroo TN300FMT2023-05-30
647261192638153K203579Infinity Gateway SuiteMSX2022-06-07
647261126312858K203088Infinity Acute Care System (IACS) Monitoring SystemMHX2022-02-01
647261543244484K200859Infinity M300MHX2020-08-28
647251031803981K182977Isolette 8000 PlusFMZ2018-11-21
647251050683443K172656BiliLuxLBI2018-05-01
647251778672988K172154Isolette 8000 plusFMZ2018-04-19
647261175483872K152407Infinity Delta, Infinity Delta XL, Infinity KappaMHX2015-09-23
647261258207932K151860Infinity CentralStation WideMHX2015-09-02
647261645019414K141756INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATIONMSX2014-12-12
647251057763122K141565GLOBE-TROTTER GT5400FPL2014-09-10
647251206732922K133175DRAEGER JAUNDICE METER JM-105MQM2014-11-13
647261015635870K130711INFINITY CENTRALSTATION WITH INFINITY M300MHX2013-04-11
647251834461399K120642RESUSCITAIRE WITH AUTOBREATHFMT2012-11-02
647261041296909K113798INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SETMHX2012-03-22
647251308972471K113206NANOBLUTM 500LBI2012-02-17
647261694293972K102968INFINITY CNAP SMARTPODDXN2011-02-18
647261390991427K093788INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTIONMHX2010-03-08
647261352376586K082888INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997DQA2008-11-26
647262046646983K073113INFINITY PICCO POD, MODEL MS16734DXG2008-01-03
647261804862730K070566INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XLMHX2007-06-04
647261950566620K061379INFINITY TELESMART TELEMETRY SYSTEMMHX2007-02-16
647261867863385K061329INFINITY MASIMO SET SP02 PODDQA2006-07-07
647261269831947K060223INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEMMHX2006-04-12
647261353198615K053484INFINITY GAMMA / GAMMAXL, INFINITY VISTAMHX2006-02-22
647252015844469K053399VERSALET 7700 CARE CENTERFMZ2006-08-04
647261207168481K050974DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERSDRQ2005-04-29
647261663998606K043549INFINITY GATEWAY SUITE, VF4MHX2005-01-21
647261875582276K042904INFINITY KAPPA XLTMHX2005-02-18
647252016554863K042522JAUNDICE METER, MODEL JM 103MQM2005-07-06
647261883928552K042003INFINITY TRIDENT NMT PODKOI2004-09-01
647261201849746K040188INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULENHP2004-04-14
647251449951920K033498NARKOMED 6400, MODEL NM6400BSZ2004-04-26
647251518332844K031387ISOLETTE INFANT INCUBATOR, MODEL C2000EFMZ2003-08-01
647261835344576K003550INFINITY ETCO2 + RESPIRATORY MECHANICS PODCCK2001-03-07
647251552437597K003335RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMERFMT2000-11-17
647251661068163K001242ISOLETTE INFANT INCUBATOR, MODEL C2HSFMZ2000-07-13
647251634143623K001019TI500 GLOBE-TROTTER TRANSPORT SYSTEMFPL2000-04-27
647261134999538
647261335413908
647261606188385
647261915329208
647261940572811

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MHX162026-08-20
FMT72025-01-17
FMZ72018-11-21
LBI52018-05-01
MSX32024-07-12
FPL32014-09-10
MQM22014-11-13
DQA22008-11-26
CCK22001-03-07
DXN12011-02-18
DXG12008-01-03
DRQ12005-04-29
KOI12004-09-01
BSZ12004-04-26
NHP12004-04-14
CCL11999-11-03
OLT11999-06-24
KLK11998-08-12
FLL11981-03-31

PMN#

45 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next