FDA.reportPublic FDA data

MedSource Labs, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30036746983003674698MedSource Labs, LLC1Y2026-01-018600 Shelby Court, Suite 100 Chanhassen MN US 55317

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
603921879264493K261041ClearSafe Closed SystemFOZ2026-07-10
603922047792109K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterFOZ2026-07-09
603921979846450K223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety CatheterFOZ2023-09-15
603921493512896K222889FlowArt® Needle-Free Split Septum ValveFPA2023-01-20
603921041005882K222034RightLance Blood Lancing SystemQRL2022-09-07
603921514099525K210433Surgical Face Mask (Ear loops and Tie-on)FXX2021-06-07
603921547305084K203620Aneroid SphygmomanometerDXQ2021-03-23
603921311072164K201843Infrared ear and forehead thermometer, model YI-100FLL2020-10-23
603921353909886K193278MedSource CathMED IV CatheterFOZ2020-08-07
603921144936307K180984Maxcon Sharps ContainerMMK2019-01-03
603921997006135K173246ANEROID SPHYGMOMANOMETERDXQ2018-05-30
603921050230551K172870Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100JFLL2018-02-13
603921255443156K171888Non-contact infrared body thermometerFLL2018-07-23
603921666650972K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterFOZ2016-11-03
603921271655792K161560Fingertip Pulse Oximeter MD300CN310DQA2016-10-05
603921003639148K150611MedSource ClearSafe Safety IV CatheterFOZ2015-07-15
603921176258619K150333MedSource Sharps DartMMK2015-05-08
603921133507015K143127CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only styleCCK2015-02-13
603921401131853K142097SELEC-3 I.V.ADMINISTRATION SETFPA2014-08-29
603921968669639K140442MEDSOURCE SELECTABLE IV SETLHI2014-04-22
603921287330021K140402MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SETLHI2014-04-03
603921021403589K131555MEDSOURCE IV SAFETY CATHETERFOZ2014-01-31
603921370747195K120424MEDSOURCE IV ADMINSTRATION SETLHI2012-07-11
603921722543721K102718DIGITAL THERMOMETER; DIGITAL THERMOMETERFLL2010-12-13
603921144611744K093327INTCO TAB ELECTRODEDRX2010-05-10
603921303198486K091794CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202CAF2010-01-28
603922018341383K090361REMOTE INFRARED THERMOMETER, MODEL RC002FLL2009-10-08
603921716529743K082965DS-A BLOOD GLUCOSE MONITORING SYSTEMCGA2009-12-07
603921373899262K081516MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORTCBP2008-08-26
603921810247172K080339MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)BTR2008-10-27
603921849806668K070371FINGERTIP PULSE OXIMETER MD300CDQA2007-08-13
603921634109849K043286ANEROID SPHYGMOMANOMETER, MODEL BK2002DXQ2005-01-13
603921392741166K002846HEADSTAR'S MANUAL EMERGENCY RESUSCITATORBTM2001-06-06
603921081207917
603921122481103
603921133855742
603921155665056
603921164832848
603921191664936
603921204085497
603921204100688
603921225136123
603921240861104
603921255028480
603921257857363
603921265267221
603921269870152
603921278312224
603921395009146
603921494158287
603921500277228
603921595531143
603921606879172
603921620534844
603921627628405
603921672858600
603921734025163
603921762410246
603921781947634
603921875706869
603921890939966
603921990790583
603922004524903
603922013568763
603922022984634
603922055668767
603921008717823
603921024938362
603921035474546
603921064960152
603921076124940
603921079430103
603921111478826
603921136712034
603921146111830
603921173359817
603921197347520
603921211885760
603921233359234
603921234621066
603921254317874
603921332983872
603921347022677
603921387611985
603921399576750
603921438774891
603921482680107
603921571228191
603921632703096
603921696315220
603921704226768
603921706288017
603921712467420
603921743462117
603921745116925
603921770527958
603921790543037
603921802529893
603921819321827
603921832420125
603921858448479
603921862579980
603921870768039
603921887120105
603921900693719
603921924167057
603921972189386
603921976976564
603921988268542
603922010366749
603922011003109
603922027355062
603922032836385
603922033066254

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FOZ82026-07-10
FLL52020-10-23
DXQ32021-03-23
LHI32014-04-22
FPA22023-01-20
MMK22019-01-03
DQA22016-10-05
CBP22008-08-26
QRL12022-09-07
FXX12021-06-07
CCK12015-02-13
DRX12010-05-10
CAF12010-01-28
CGA12009-12-07
BTR12008-10-27
BTM12001-06-06

PMN#