FDA.reportPublic FDA data

CUSTOMED, INC.

Matched from indexed company URL: CUSTOMED INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
26487272648727CUSTOMED, INC.1Y2026-01-01CALLE IGUALDAD No. 7 Fajardo PR US 00738

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
M20890029842CUSTOMED - CUSTOMED ADULT DISPOSABLE BRIEF MEDIUM787.622.5151customerservice@prhospital.com
M20890029852CUSTOMED - CUSTOMED ADULT DISPOSABLE BRIEF REGULAR787.622.5151customerservice@prhospital.com
M20890029862CUSTOMED - CUSTOMED ADULT DISPOSABLE BRIEF LARGE787.622.5151customerservice@prhospital.com
M2089004048C1CUSTOMED - CUSTOMGUARD DISPOSABLE NITRILE EXAM GLOVES SMALL POWDER FREE CHEMOTHERAPY DRUG TESTED787-622-5151customerservice@prhospital.com
M2089004049C1CUSTOMED - CUSTOMGUARD DISPOSABLE NITRILE EXAM GLOVES MEDIUM POWDER FREE CHEMOTHERAPY DRUG TESTED787.622.5151customerservice@prhospital.com
M2089004050C1CUSTOMED - CUSTOMGUARD DISPOSABLE NITRILE EXAM GLOVES LARGE POWDER FREE CHEMOTHERAPY DRUG TESTED787.622.5151customerservice@prhospital.com
M2089004051C1CUSTOMED - CUSTOMGUARD DISPOSABLE NITRILE EXAM GLOVES X-LARGE POWDER FREE CHEMOTHERAPY DRUG TESTED787.622.5151customerservice@prhospital.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
425821693793261K993258SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVESLZA1999-10-27
425821278328747K992821SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVESLYZ2000-03-10
425821675765110K992219POWDERED LATEX STERILE SURGICAL GLOVESKGO1999-07-30
425821570428495K981393MICROCOOL SURGICAL GOWNFYA1998-07-10
425821117253900K980494SUPERGLOVESLYY1998-06-09
425821365374721K980071SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVESLYY1998-03-13
425821881577498K974647FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633KKX1998-01-05
425821879052117K974042AMSURE CLEANSING ENEMA SETFCE1997-12-19
425821222912533K972306POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICELZA1997-09-12
425821274516771K971929AMSINO URINARY LEG BAGKNX1997-08-06
425821943784230K971920GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)FYA1997-12-04
425821748731123K963749HIGH PRESSURE INJECTION LINESDTL1996-12-17
425821833980923K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)KNX1996-10-04
425821603914551K962596CUSTOMED BLOOD EXTRACTION KITGJE1996-09-27
425821365390249K962161BAXTER NEBULIZER CAP MODEL 2D0868CAF1996-08-15
425821763693890K961442UNIVERSAL DRAINAGE TRAYFCM1996-05-09
425821903904667K951528AMSINO DISPOSABLE VIGINAL SPECULUMHIB1995-05-11
425821256053037K950295WOUND CLOSURE/LACERATION TRAYLRO1995-04-18
425821020220472K943954ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTERHIF1994-11-15
425822012323084K941900POWDERED LATEX EXAM GLOVESLYY1994-06-21
425821587376714K935782DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIESDXN1994-08-01
425821971643820K934310BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATORBTM1993-12-14
425822068866928K930986BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560CBT1993-07-14
425821757047666K930411UNIVERSAL WHEELCHAIRIOR1993-03-31
425821475896386K926055THE MILLER NEBULIZER SYSTEMCAF1993-02-03
425821212489656K925022SURGICAL TRAY (STERILE)LRD1993-04-26
425821635980339K925021TPN TRAY (STERILE)MCY1993-06-07
425821136426420K925020TRACHEOSTOMY CARE KIT (STERILE)JOH1993-07-07
425821086859375K925018IV PREP KIT W/O DRESSING (NON-STERILE)LRS1993-08-27
425821771149842K925016PREP SHAVE KIT (NON-STERILE)LRO1993-04-26
425821446132305K925015STERILE SUTURE REMOVAL KITMCZ1993-06-07
425821823266692K924809IRRIGATION TRAY W/ BULB SYRINGEKYZ1993-06-07
425822038761152K922492SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTERCAH1992-08-24
425821355043285K915301ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCKDTL1992-12-11
425821577303695K912492EVACUATION/IRRIGATION/ELECROSURGICAL DEVICEGCJ1991-10-21
425821799689205K911732ADVANCE DISPOSABLE CONTROL SYRINGEIZI1991-09-16
425821713737708K911710HEPARIN COATED THERMODILUTION CATH & ACCESSORIESDQO1991-10-23
425821346660875K904694CUSTOMED ANGIODRAPE PACK FEMORALKKX1991-01-02
425821006191453K904693CUSTOMED CARDIOVASCULAR PACKKKX1991-01-02
425821601245039K902886CUSTOMED BASIC PACK IIIKKX1990-09-19
425821136154307K902884CUSTOMED BASIC PACK IKKX1990-09-19
425822073497184K902274CUSTOMED CYSTO PACK IFAJ1990-09-20
425821288391388K902273O. B. PACK IIIHHD1990-08-21
425821145186617K902272O. B. PACK IIHHD1990-08-15
425821505167347K902271O. B. PACK IHHD1990-08-15
425821414684337K902191CUSTOMED LAP PACK IIKKX1990-10-31
425821966733036K902032O. B. PACK IVHFC1990-09-28
425821441275343K902031CUSTOMED LAP PACK IVKKX1990-07-12
425821246063246K902030CUSTOMED LAP PACK IIIKKX1990-07-12
425821940137714K902029CUSTOMED LAP PACK IKKX1990-07-12
425821542688493K901705CUSTOMED CYSTO PACK IIKKX1990-10-31
425821870648010K894350SALTER LABS MODEL #4009 SAMPLE LINESCCK1989-10-03
425821293481058K885235SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.DSK1989-01-25
425821163641952K882284SURGEONS CAPFYF1988-06-23
425821618450540K882283BOUFFANT CAPFYF1988-06-23
425821978762183K882280COVER, SHOE OPERATING ROOMFXP1988-06-23
425821134618447K881396OPERATING ROOM TOWELS -STERILE & NON-STERILEKKX1988-04-29
425821406966022K881395GAUZE AND LAP SPONGES -STERILE & NON-STERILEEFQ1988-04-28
425821679634036K870417RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAYFSM1987-03-05
425821693189249K862801SPUNGUARD PLUS SURGICAL DRAPEKKX1986-08-07
425821344972880K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATORDRS1986-02-26
425821000187894K854095BIOPSY TRAY I & IILRO1985-11-25
425821657198680K842115SPUNGARD & SURG. DRAPES-GOWNS & PACKSKKX1984-06-11
425821258906418K840824HEPARIN COATED THERMODILUTION CATHETERSKRB1984-05-23
425821559060133K810637COBE DISPOSABLE PRESSURE TRANSDUCERDRS1981-04-23
425821792581894K810126CURITY CURAD BANDAGESKGX1981-02-06
425821651171779K800562DISPOSABLE HAND HELD NEBULIZERCAF1980-03-25
425821517434461K781558PRESSURE MONITORING INJECTION LINESDQO1978-10-10
425821953643621K780271COBE STOPCOCKDTL1978-03-02
425821004110560K780126DILATOR, VESSEL & INTRODUCER, SHEATHDRE1978-03-02
425821624481156K171276Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy DrugsKGO2017-08-21
425821730217780K120045EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IVFYA2012-06-12
425821211319371K112294
425821429728448K111535EMM SURGICAL GOWN - SPUNLACE WITH PE LAYERFYA2011-08-26
425821999049577K110981
425821305313376K103212ROUGHRIDERIOR2011-01-03
425821740447507K102861SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)KKX2011-01-13
425821297858813K102666KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIMKKX2010-11-09
425821795919465K101689EMM EQUIPMENT COVER-POLYTHYLENEKKX2010-09-20
425821815724497K101688EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004KKX2010-09-20
425821643515982K101598EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)KKX2010-10-04
425821417060758K101593EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXLFYA2010-09-03
425821356090194K093570POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLORLYZ2009-12-04
425821389584233K093169SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)FYA2009-11-12
425821745670924K092338MEDAX UNIPERSONALE SRLKNW2011-05-27
425821408170564K091272BESMED JET NEBULIZER BOTTLE SETCAF2009-11-10
425821865774340K083234KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100KKX2009-03-25
425821610805962K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSEZL2008-10-08
425821365526825K081633PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKSFXX2008-08-11
425821922386979K070411AMSURE NEBULIZERCAF2007-10-01
425821356572020K050887GONGDONG DISPOSABLE VAGINAL SPECULUMHIB2005-07-11
425821654033130K050532CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WALYY2005-04-14
425821271221889K050528POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK)LZA2005-05-19
425821850923114K042683WELL LEAD ENDOTRACHEAL TUBEBTR2005-02-18
425821486789381K041436SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2KGO2004-08-20
425821943811542K041190A&I POWER WHEELCHAIR, PC-401ITI2004-05-25
425821689463145K030228POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVESKGO2003-03-14
425821341023155K013443POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2LYY2001-11-29
425821108382098K010198STERILE POWDERED LATEX SURGEON GLOVESKGO2001-02-23
425821574706453K001951PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306FXX2000-09-08
425821494793935K001872I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411FPA2000-09-07
425821010789389K001858OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITEKKX2000-08-17
425821785013351
425821013772620
425821028884471
425821033918356
425821053954241
425821080201841
425821088355116
425821101965471
425821137677134
425821144419364
425821150402616
425821163202450
425821196242313
425821247723761
425821300671732
425821306745536
425821313866825
425821324423721

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KKX202011-01-13
FYA62012-06-12
KGO52017-08-21
CAF52009-11-10
LYY52005-04-14
LZA32005-05-19
DTL31996-12-17
LRO31995-04-18
HHD31990-08-21
IOR22011-01-03
LYZ22009-12-04
FXX22008-08-11
HIB22005-07-11
KNX21997-08-06
DQO21991-10-23
FYF21988-06-23
DRS21986-02-26
KNW12011-05-27
EZL12008-10-08
BTR12005-02-18
ITI12004-05-25
FPA12000-09-07
FCE11997-12-19
GJE11996-09-27
FCM11996-05-09
HIF11994-11-15
DXN11994-08-01
BTM11993-12-14
LRS11993-08-27
CBT11993-07-14
JOH11993-07-07
KYZ11993-06-07
MCZ11993-06-07
MCY11993-06-07
LRD11993-04-26
CAH11992-08-24
GCJ11991-10-21
IZI11991-09-16
HFC11990-09-28
FAJ11990-09-20

PMN#

GUDID#

118 records. Showing 1-40. Next