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NextPhase Medical Devices LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12254923001237338NextPhase Medical Devices LLC1N2026-01-0188 Airport Dr ROCHESTER NH US 03867

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
00859758005009Sontek Medical - Suction Safe™ Swivel Y508-261-0800lsampson@nextphasemed.com
00859758005023Sontek Medical - Bronch Safe™ Swivel Y508-261-0800lsampson@nextphasemed.com
00859758005047Sontek Medical - Bronch Safe™ Swivel Y508-261-0800lsampson@nextphasemed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
524611442873347K983112RESPIRATORY HUMIDIFIER, MODEL # MR850BTT1998-11-10
524611648620477K972992CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORSCCL1998-03-30
524611229586531K972398STEALTHSTATION PASSIVE INSTRUMENT OPTIONHAW1997-09-16
524611632185944K181170Trilogy Evo UniversalCBK2019-07-18
524611566518665K181166Trilogy EvoCBK2019-07-18
524611582993763K143646MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb CircuitBTT2015-03-05
524612034401318K141833STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATIONHAW2015-03-25
524611350032219K133665MALLEABLE SUCTION INSTRUMENTSPGW2014-03-13
524611300617221K131425NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTEROLO2013-08-14
524611533549472K122432ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITSBZE2012-12-06
524611929994072K120819STALIF COVE2012-08-31
524611689162280K111732AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALERGEI2011-12-05
524611317230238K103767DUAL HEATED INFANT VREATHING CIROUITSBZE2012-04-16
524611714009337K101301STALIF MIDLINEMAX2010-09-24
524611315872505K073495TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHTGEI2008-01-09
524611222490168K063639AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1GEI2007-02-22
524611459373167K052859AQUAMANTYS PUMP GENERATOR SYSTEMGEI2005-10-25
524611591954981K050438STEALTHSTATION SYSTEM UPDATEHAW2005-06-02
524611089301357K001284STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEMHAW2000-06-12
524611135435963
524611694713595
524611904543739
524611019566395
524611089301357
524611190948223
524611229586531
524611290145164
524611300617221
524611315872505
524611334098082
524611350032219
524611381990975
524611459373167
524611466327540
524611471734297
524611591954981
524611632564928
524611652570347
524611740129454
524611839912800
524611916595991
524611945544925
524612034401318
524612048812900

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HAW42015-03-25
GEI42011-12-05
CBK22019-07-18
BTT22015-03-05
BZE22012-12-06
PGW12014-03-13
OLO12013-08-14
OVE12012-08-31
MAX12010-09-24
CCL11998-03-30

GUDID#