BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HOLLISTER, INC.

    Reg #: 2320961 · FEI: 3003172243 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    84
    Establishment Types
    1
    Classifications
    28

    Registration Details

    Registration Name
    HOLLISTER, INC.
    Registration Number
    2320961
    FEI Number
    3003172243
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    12011 VOLUNTEER BLVD
    City
    Mount Juliet
    State
    TN
    ZIP
    37122
    Country
    US

    Regulatory Submissions

    510(k) Number
    K932855

    Owner / Operator

    Firm Name
    Hollister Inc.
    Operator Number
    1480288
    Address
    2000 HOLLISTER DR., --
    City
    Libertyville
    State
    IL
    Postal Code
    60048
    Country
    US
    Correspondent
    Sofia Abreu Read

    Products

    Device Name Product Code
    Bag, Urine Collection, Leg, For External Use, Non-Sterile NNW
    Enema Kit FCE
    Bag, Urine Collecting, Ureterostomy EXG
    Catheter, Irrigation GBX
    Device, Paste-On For Incontinence, Non-Sterile NOA
    Tubes, Gastrointestinal (And Accessories) KNT
    Catheter, Urethral GBM
    Ostomy Care Kit PQE
    Rod, Colostomy EZP
    Irrigator, Ostomy EXD
    Bag, Stomal GDS
    Solvent, Adhesive Tape KOX
    Dressing, Wound, Occlusive NAD
    Catheter, Straight EZD
    Device, Fixation, Tracheal Tube CBH
    Bedpan FOB
    Bandage, Liquid KMF
    System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile NNZ
    Bandage, Liquid, Skin Protectant NEC
    Appliance, Colostomy, Disposable EZS
    Catheter Care Tray OHR
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Protector, Ostomy EXE
    Collector, Ostomy EXB
    Catheter, Urological KOD
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
    System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile EYZ
    Cement, Stomal Appliance, Ostomy EZR

    Proprietary Names

    Latex-Free Extension Tubing Hollister Leg Bag Straps Extension Tubing with Connector Urinary Leg Bag Urinary Leg Bag Holsters Deluxe Urinary leg Bag Straps Conform 2 Impression - C Nova NovaLife 1 Dansac New Image HOLLISTER UROSTOMY BAGS Center Point Lock Karaya 5 Securi-T USA Nova 2 NovaLife Urostomy Bags Moderma Flex NovaLife 2 GX+ NovaLife 2 Invent First Choice Tandem NovaLife 1 GX+ Compact Premier Female Urinary Pouch Male Urinary Pouch Vertical Drain/Tube Attachment Device VaPro Plus Pocket (40cm/16 inch) ModermaFlex LOOP OSTOMY BRIDGE HOLLISTER HOLLISTER STOMA BAGS HOLLISTER DRAINING WOUND MANAGEMENT STOMA BAGS Adapt Restore Infyna Chic Onli (LCC) AnchorFast AnchorFast Guard Select AnchorFast SlimFit AnchorFast Guard Deluxe Urinary Leg Bag Straps Extension Tubing with connector VaPro Pocket VaPro Plus Pocket Apogee Catheter Insertion Kit VaPro Pocket Plus Kit BEDSIDE URINE COLLECTOR Vented Leg Bag TRE CeraPlus Premium Nova 1 HolliHesive Karaya VaPro VaPro Plus Suavita Pouchkins Hollister Solo Holligard Fecal Collectors DuoSoft m9 Novalife 1 Advance Advance Plus Pocket Advance Plus Urinary Night Drainage Bags InstantCath VaPro Pocket (40cm/16 inch) Apogee IC ADAPT PREMIUM KARAYA Apogee Plus InstantCath Protect

    Establishment Types

    Repack or Relabel Medical Device