BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CUSTOMED, INC.

    Reg #: 2648727 · FEI: 2648727 · Expires 2026
    View on FDA
    Products
    111
    Proprietary Names
    25
    Establishment Types
    3
    Classifications
    111

    Registration Details

    Registration Name
    CUSTOMED, INC.
    Registration Number
    2648727
    FEI Number
    2648727
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    CALLE IGUALDAD No. 7
    City
    Fajardo
    State
    PR
    ZIP
    00738
    Country
    US

    Regulatory Submissions

    510(k) Number
    K083234

    Owner / Operator

    Firm Name
    CUSTOMED, INC.
    Operator Number
    9000786
    Address
    CALLE IGUALDAD #7, --
    City
    Fajardo
    State
    PR
    Postal Code
    00738
    Country
    US

    Products

    Device Name Product Code
    Drape, Surgical, Antimicrobial KKX
    Gauze / Sponge,Nonresorbable For External Use NAB
    Cap, Surgical FYF
    Wheelchair, Mechanical IOR
    Polymer Patient Examination Glove LZA
    Fiber, Medical, Absorbent FRL
    Insufflator, Laparoscopic HIF
    Bandage, Elastic FQM
    Saw, Manual And Accessories GDR
    Staple, Removable (Skin) GDT
    Pad, Menstrual, Unscented HHD
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Hemostat HRQ
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Nebulizer (Direct Patient Interface) CAF
    Scalpel, One-Piece GDX
    Vinyl Patient Examination Glove LYZ
    Suit, Surgical FXO
    Bandage, Cast ITG
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Bed, Ac-Powered Adjustable Hospital FNL
    Speculum, Vaginal, Nonmetal HIB
    Mask, Surgical FXX
    Enema Kit FCE
    Suture Removal Kit MCZ
    Catheter And Tip, Suction JOL
    Tube, Tracheal (W/Wo Connector) BTR
    Handle, Scalpel GDZ
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Tube, Aspirating, Flexible, Connecting BYY
    Gown, Examination FME
    Tray, Blood Collection GJE
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Speculum, Ent EPY
    Adaptor, Hygiene ILS
    Laparoscope, General & Plastic Surgery GCJ
    Latex Patient Examination Glove LYY
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Curette HTF
    Set, Administration, Intravascular FPA
    Arterial Blood Sampling Kit CBT
    Speculum, Vaginal, Metal HDF
    System, X-Ray, Angiographic IZI
    Aid, Transfer IKX
    Tubing, Pressure And Accessories BYX
    Tips And Pads, Cane, Crutch And Walker INP
    Accessories, Catheter KGZ
    Tape And Bandage, Adhesive KGX
    Wound Dressing Kit MCY
    Container, Specimen, Sterile FMH
    Syringe, Irrigating (Non Dental) KYZ
    Cannula, Nasal, Oxygen CAT
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Guide, Needle, Surgical GDF
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Tube Tracheostomy And Tube Cuff JOH
    Gown, Surgical FYA
    Retractor GAD
    Gown, Isolation, Surgical FYC
    Accessory, Surgical Apparel LYU
    Dispenser, Liquid Medication KYX
    Garment, Protective, For Incontinence EYQ
    Applicator, Ent Drug LRD
    Sound, Uterine HHM
    Aspirator, Endocervical HFC
    Probe, Thermodilution KRB
    Filter, Bacterial, Breathing-Circuit CAH
    General Surgery Tray LRO
    Gauze/Sponge, Internal EFQ
    Container, Specimen, Non-Sterile NNI
    Scissors, General, Surgical LRW
    Catheter, Retention Type, Balloon EZL
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
    Bedpan FOB
    Elevator HTE
    Tray, Surgical, Instrument FSM
    Surgeon'S Gloves KGO
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Bag, Ice KYR
    Catheter, Intravascular, Diagnostic DQO
    Non-Surgical Gown OEA
    Walker, Mechanical ITJ
    Bath, Sitz, Nonpowered KTC
    Catheters, Suction, Tracheobronchial BSY
    Instrument, Biopsy KNW
    Wheelchair, Powered ITI
    Forceps, Biopsy, Gynecological HFB
    Transducer, Blood-Pressure, Extravascular DRS
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Cane IPS
    Trap, Sterile Specimen BYZ
    Set, Tubing And Support, Ventilator (W Harness) BZO
    I.V. Start Kit LRS
    Tourniquet, Nonpneumatic GAX
    Urinal FNP
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Wrap, Sterilization FRG
    Computer, Blood-Pressure DSK
    Forceps HTD
    Brush, Scrub, Operating-Room GEC
    Blade, Scalpel GES
    Cover, Shoe, Operating-Room FXP
    Container, Liquid Medication, Graduated KYW
    Ring Cutter FNS
    Bedding, Disposable, Medical KME
    Basin, Emesis FNY
    Dressing, Wound, Occlusive NAD
    Medical Glove, Specialty LZC

    Proprietary Names

    Customed Customed Inc customed CUSTOMED INC. Suture removal kit CUSTOMED CUSTOMED INC surgical tray catheter kit CUTOMED INC BLOOD GAS KIT WITH PROTECTOR surgical drape wound dressing kit SYRINGE, IRRIGATING Cystoscope and accessories ANESTHESIA CUSTOM CIRCUIT HOS Trach Tube and Cuff surgical gown MALE AMBULATORY KIT SURGICAL TRAY ASPIRATOR Surgical Tray Biopsy kit IV Kit sterilization wrap

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Sterilize Medical Device for Another Party (Contract Sterilizer)