FDA.reportPublic FDA data

Melissa Gray

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96115003001104093Melissa Gray1N2026-01-016 TECH DRIVE Andover MA US 01810
30131562503013156250Melissa Gray1N2026-01-016 Tech Dr Andover MA US 01810

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
398642048865808K992608ATC OPTION FOR EVITA 2 DURA AND EVITA 4CBK1999-08-24
398641793739376K984577DRAGER OXYLOG 2000CBK1999-01-22
398641860720296K983219NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900CBK1998-12-07
398641686536133K982789MEDICAL AIR COMPRESSOR, MODEL # 8413419BTI1998-10-29
398641158534857K981773DRAGER-VAPOR 19.3CAD1998-07-06
398641174095993K981472DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUSCAD1998-05-07
398641898199291K980642EVITA 4 (8411900)CBK1998-09-04
398641605850046K974176BABYLOG 8000 PLUSCBK1998-06-17
398641714701756K973051DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUSCAD1997-10-30
398641367202219K971923DRAGER-VAPOR 2000CAD1997-09-16
398641213047768K971198BABYTHERM 8004 BABYTHERM 8010FMT1997-10-03
398641757044554K970165EVITA 2 DURACBK1997-08-26
398641050940240K961687EVITA 4CBK1996-12-13
398641664838576K954611DRAGER PT4000 PHOTOTHERAPY SYSTEMLBI1995-12-01
398641131590702K950853OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORSCBK1996-11-05
398641171503423K946306SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEMDSI1995-06-27
398641728323388K942055DRAGER-VAPOR 19.1CAD1995-01-27
398641574159165K926292BABYLOG 8000 INFANT VENTILATORCBK1994-04-19
398641032185778K903089BABYLOG 8000 INFANT VENTILATORCBK1991-06-10
398641819290080K821650DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERSCAD1982-06-29
398641320805815K253647Evita (V800); Evita (V600)CBK2026-05-07
398641639594383K252827IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)DSA2025-12-01
398641676623042K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)BSZ2026-05-21
398641540570274K251619Babyleo TN500FMZ2026-02-13
398641318027354K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL2025-04-04
398641324499592K230931AtlanBSZ2023-07-23
398641743061075K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)BZE2023-06-14
398641163229020K222207Babylog VN800, Babylog VN600CBK2023-05-16
398641999518526K222024Evita V800, Evita V600CBK2023-05-16
398641407891573K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusCAH2022-12-07
1960451699060898K221494Quality Mix Blender, OxymixerBZR2023-01-23
398641695196534K221118CO2 Mainstream SensorCCK2023-04-05
398641597278230K182859Babyleo TN500FMZ2019-02-22
398641716793994K142032MRI PATIENT MONITORING SYSTEM TESLA M3MWI2015-05-07
398641630692707K133886PERSEUS A500BSZ2014-06-20
398641158541285K131502SEATTLE - PAPBZD2013-10-11
398641612598380K123776POLARIS 100/200FTD2013-03-08
398642049789453K121999GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBEFLL2013-02-28
398641195384654K121886SAVINA 300 SAVINA 300, COUNTRY VARIANTSCBK2014-08-08
398641710742081K103625OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICECBK2011-10-06
1960451739892758K103324PRECISION LIQUID OXYGEN SYSTEMBYJ2011-04-21
398642063946051K103035SMARTPILOT VIEW MODEL MK04500BSZ2012-03-28
398641001835623K102618VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATEDBTT2010-12-10
398641425828743K100941INFINITY MCABLE - MAINSTREAM CO2CCK2010-04-23
398641706651892K093633INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARECBK2010-03-30
398641916571946K093632INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARECBK2010-04-05
398641058218722K092999NBP CUFFDXQ2009-11-24
398641663959692K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310BYE2010-08-06
398641935193492K083050EVITE XLCBK2008-12-29
398641561628354K082600OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)CBK2008-11-26
398641150903776K081743CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKSCBK2008-09-22
398641840125297K081447FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLOBSZ2008-10-08
398641859578665K072885CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110CBK2008-04-07
398641742254646K072884FABIUS MRIBSZ2008-07-30
398641387530229K072002FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55CAH2008-01-31
398641450301912K062267OXYLOG 3000CBK2006-10-31
398641603961499K060254MODIFICATION TO INFINITY EXPLORERMSX2006-04-04
398641276825448K051628INFINITY MONITORS WITH SCIO MODIFICATIONSMHX2005-07-20
398641251301918K051263EVITAXL WITH OPTION SMARTCARECBK2005-07-12
398641376844085K042607PRIMUS USBSZ2004-11-26
398641580132859K042419FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEMBSZ2004-10-08
398641742691132K042276D-VAPORCAD2004-09-23
398641842116697K042086FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEMBSZ2004-08-31
398642017556477K041956EMG - ESSENTIAL GAS MODULE, MODEL M1013ACCK2004-08-09
398641578302047K041622MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEMBSZ2004-07-08
1960451328873944K041122PRECISION LIQUID OXYGEN SYSTEMBYJ2004-10-04
398641007774890K040847MODIFICATION TO VAMOS ANESTHETIC GAS MONITORCCK2004-06-17
398641872089325K040642LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINACBK2004-06-02
398641021795746K031400FABIUS TIRO ANESTHESIA SYSTEMBSZ2003-07-15
398641741084665K030624MODIFICATION TO FABIUS GS ANESTHESIA SYSTEMBSZ2004-03-17
398641125345455K023289OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072CBK2003-01-15
398641841838953K012177VENTVIEW, MODEL 8414095CBK2001-09-04
398641434526941K012139VAMOS ANESTHETIC GAS MONITORCCK2002-01-17
398641285878813K011404FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GSBSZ2002-02-22
398641750216517K010793OXYLOG 1000, MODEL 2M86840CBK2001-12-20
398641898758805K010724SOLA 700,SOLA 500, SOLA 300FTD2001-06-07
398641736648351K010093NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474CBK2001-06-14
398642059795240K003068SAVINACBK2001-06-25
398641455337928K003067CALEOFMZ2000-12-13
398641975131910
398641062180878
398641110720506
398641134440488
398641155655887
1960451163515919
398641164732038
398641165213303
398641192116614
398641245719274
398641331807071
398641400231506
398641434638544
398641469306778
398641487343899
398641512244650
398641530638927
398641542451396
1960451563563785
398641576189975
398641617433270
398641635605479
398641692065755
398641714136746
398641764725345
398641771023180
398641831430885
398641842843827
398641861204797
398641976523282
1960452044690590
398642070567088

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CBK292026-05-07
BSZ132026-05-21
CAD72004-09-23
CCK62023-04-05
FMZ32026-02-13
CAH22022-12-07
FTD22013-03-08
BYJ22011-04-21
DSA12025-12-01
BTL12025-04-04
BZE12023-06-14
BZR12023-01-23
MWI12015-05-07
BZD12013-10-11
FLL12013-02-28
BTT12010-12-10
BYE12010-08-06
DXQ12009-11-24
MSX12006-04-04
MHX12005-07-20
BTI11998-10-29
FMT11997-10-03
LBI11995-12-01
DSI11995-06-27