FDA.reportPublic FDA data

DUKAL LLC

Matched from indexed company URL: Dukal LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24359461000137528DUKAL LLC1Y2026-01-012 Fleetwood Ct. Ronkonkoma NY US 11779

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
10665973029488Unipack - FitMe Lab Coats Large Black+1(631)656-3800kmckigney@dukal.com
10665973029495Unipack - FitMe Lab Coats Medium Black+1(631)656-3800kmckigney@dukal.com
10665973029501Unipack - FitMe Lab Coats Small Black+1(631)656-3800kmckigney@dukal.com
10665973029518Unipack - FitMe Lab Coats X-Large Black+1(631)656-3800kmckigney@dukal.com
10665973029525Unipack - FitMe Lab Coats XX-Large Black+1(631)656-3800kmckigney@dukal.com
10665973029532Unipack - FitMe Lab Coats Large Sky Blue+1(631)656-3800kmckigney@dukal.com
10665973029549Unipack - FitMe Lab Coats Medium Sky Blue+1(631)656-3800kmckigney@dukal.com
10665973029556Unipack - FitMe Lab Coats Small Sky Blue+1(631)656-3800kmckigney@dukal.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
458801390998310K993764MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCHKCT1999-12-16
458801271628268K981970ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXIELW1998-09-02
458801368166464K971849CYTOLOGY BRUSHHHT1997-07-24
458801105756901K964321GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)LYZ1997-01-09
458801997586426K955476DUKAL TRANSPARENT WOUND DRESSINGMGP1996-01-18
458801467119978K953505BURNAID BURN FIRST AID DRESSINGMGQ1996-02-09
458801192256567K940440DUKAL NON-WOVEN GAUZEEFQ1994-03-09
458801201461671K940339IODOFORM PACKAGING STRIPFRO1994-02-25
458801275877717K936095GAUZE SPONGEEFQ1994-02-02
458801885487493K931005DUKAL SKIN CLOSURE STRIPFPX1993-07-14
458801407057864K903590KEJUMP DIGITAL CLINICAL THERMOMETERFLL1990-10-22
458801962221402K861154ALBA HEALTH CARE PLAIN PACKING STRIPEFQ1986-04-15
458802048405208K850241ALBA HEALTH CARE NON-ADHERING DRESSINGFRO1985-03-12
458801837147714K813535XEROFORM DRESSINGFRO1982-02-04
458801295070223K780715ANEROID TYPE BLOOD PRESSURE KITDXQ1978-07-17
458801829098351K252001Collagen Wound DressingKGN2025-10-10
458801163360888K241789Non-Sterile Ultrasound Transmission GelsMUI2024-07-24
458801503409417K241036Autoclave Indicator Tape; EO Indicator TapeJOJ2024-12-17
458801118595501K221999Ultrasound Transmission GelsMUI2022-08-30
458801473170079K221755Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressingFRO2023-01-13
458801683798773K220673Sterile Silver Alginate Wound DressingFRO2023-03-16
458801282361943K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie OnFXX2021-02-16
458801981000284K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie OnsFXX2021-02-05
458801692665333K193259Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerDXQ2020-07-02
458801225297096K183263UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier EnvelopePEM2019-06-14
458801278316389K162258Self Sealing Sterilization PouchesFRG2017-04-28
458801426749776K153496Disposable Surgical Face MaskFXX2016-06-15
458801839148037K151535Cavex Cream AlginateELW2015-10-28
458801926619214K142892Powder-free Clear Vinyl Patient Examination GlovesLYZ2015-03-25
458801781216895K132709VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTERCAH2014-07-30
458801864860798K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSHOZ2013-10-29
458801582263265K121992POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORLZA2012-10-16
458801265987975K120526YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIRIOR2012-03-08
458801760737403K113689DUKAL LUBRICATING JELLYKMJ2012-05-04
458801336577469K111067JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILEFYA2011-08-02
458801199660071K110981
458802048448235K101114ADVANCIS ACTIVON TUBEFRO2011-07-26
458801526616250K091272BESMED JET NEBULIZER BOTTLE SETCAF2009-11-10
458801269631646K082542ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-ADXQ2008-09-17
458801476517734K070692DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASKMSH2007-05-30
458801358383316K070407DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUEFXX2007-03-26
458801058118951K062675GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIESGXY2007-01-04
458801679326435K061864DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560FXX2006-09-15
458801205120397K053254INFANT HEEL WARMER BY INTCOMPO2006-09-19
458801215300309K052468YK9000 SERIES MANUAL WHEELCHAIRIOR2005-10-05
458801763352223K051207CAVEX ORTHOTRACEELW2005-06-21
458801264531800K032720GEM-STIM TENS, MODELS GM3XY AND GM3AXYGZJ2003-12-10
458801644121308K020726DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGEHIB2002-05-15
458801682003037K012522WAVELENGTH MULTI-PURPOSE ULTRASOUND GELITX2001-10-18
458802038032092K011419CAVEX COLORCHANGEELW2001-07-16
458801948842924K003791CAVEX TEMPORARY CEMENTEMA2001-01-23
458801262995547K001896KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH ECDPS2001-01-08
458801005905862
458801011791689
458801032130775
458801097594878
458801119721743
458801133161815
458801139073524
458801145472579
458801171700503
458801203398273
458801205749427
458801223005085
458801245951267
458801284806529
458801292276596
458801292889346
458801343469071
458801354702144
458801364024272
458801395331365
458801423919643
458801434251291
458801469470061
458801475819823
458801503829496
458801545848387
458801548771212
458801558890023
458801561483330
458801590333448
458801595477733
458801611177989
458801633206492
458801637780547
458801645422406
458801672928259
458801683222688
458801708238975
458801722457488
458801733730632
458801734473875
458801735316651
458801757450173
458801786089054
458801797780082
458801807336656
458801809640281
458801810874171
458801829023827
458801885572947
458801886618551
458801892658229
458801915004793
458801931520573
458801962598630
458801987986296
458802013418831
458802021460895
458802036217998
458802044207708
458802047060711
458802065855409
458801001139600
458801002839172
458801015013776
458801116400321
458801127452320
458801144539856

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRO62023-03-16
FXX52021-02-16
ELW42015-10-28
DXQ32020-07-02
EFQ31994-03-09
MUI22024-07-24
LYZ22015-03-25
IOR22012-03-08
KGN12025-10-10
JOJ12024-12-17
PEM12019-06-14
FRG12017-04-28
CAH12014-07-30
HOZ12013-10-29
LZA12012-10-16
KMJ12012-05-04
FYA12011-08-02
CAF12009-11-10
MSH12007-05-30
GXY12007-01-04
MPO12006-09-19
GZJ12003-12-10
HIB12002-05-15
ITX12001-10-18
EMA12001-01-23
DPS12001-01-08
KCT11999-12-16
HHT11997-07-24
MGQ11996-02-09
MGP11996-01-18
FPX11993-07-14
FLL11990-10-22

NDC#

GUDID#

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