FDA Registration
Active
🇺🇸 United States
HOLLISTER INCORPORATED
Reg #: 1480288
·
FEI: 1480288
·
Expires 2026
Products
31
Proprietary Names
92
Establishment Types
2
Classifications
31
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Registration Details
- Registration Name
- HOLLISTER INCORPORATED
- Registration Number
- 1480288
- FEI Number
- 1480288
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2000 HOLLISTER DR.
- City
- LIBERTYVILLE
- State
- IL
- ZIP
- 60048
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193148
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Paste-On For Incontinence, Non-Sterile | NOA | Class 1 | Gastroenterology, Urology | No | 2006-09-27 |
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2020-01-16 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2006-09-27 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2022-09-14 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2006-10-17 |
| Catheter Care Tray | OHR | Class 2 | Gastroenterology, Urology | No | 2010-02-06 |
| Bag, Urine Collecting, Ureterostomy | EXG | Class 1 | Gastroenterology, Urology | No | 1992-07-21 |
| Irrigator, Ostomy | EXD | Class 2 | Gastroenterology, Urology | No | 1992-07-21 |
| Bedpan | FOB | Class 1 | General Hospital | No | 2006-10-17 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2006-05-24 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2004-06-28 |
| Rod, Colostomy | EZP | Class 2 | Gastroenterology, Urology | No | 2006-10-16 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 1995-04-19 |
| Bag, Stomal | GDS | Class 1 | Gastroenterology, Urology | No | 1992-07-21 |
| Appliance, Colostomy, Disposable | EZS | Class 1 | Gastroenterology, Urology | No | 2017-03-06 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2015-01-28 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2001-08-01 |
| Bandage, Liquid | KMF | Class 1 | General Hospital | No | 2007-11-30 |
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2006-09-27 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2016-03-08 |
| Cement, Stomal Appliance, Ostomy | EZR | Class 1 | Gastroenterology, Urology | No | 1992-07-21 |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | NNZ | Class 1 | Gastroenterology, Urology | No | 2017-03-23 |
| Ostomy Care Kit | PQE | Class 1 | Gastroenterology, Urology | No | 2022-07-14 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2007-11-30 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | Class 1 | Gastroenterology, Urology | No | 2006-09-27 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2024-04-26 |
| Device, Incontinence, Urosheath Type, Non-Sterile | NNX | Class 1 | Gastroenterology, Urology | No | 2006-09-27 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 1996-06-14 |
| Collector, Ostomy | EXB | Class 1 | Gastroenterology, Urology | No | 2006-09-27 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2007-11-13 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2006-06-14 |
Proprietary Names
Female Urinary Pouch
Male Urinary Pouch
VaPro Pocket
VaPro Plus Pocket
Latex-Free Extension Tubing
Hollister
Leg Bag Straps
Extension Tubing with Connector
Urinary Leg Bag
Urinary Leg Bag Holsters
Deluxe Urinary leg Bag Straps
Infyna Chic
Apogee
Catheter Insertion Kit
VaPro Pocket Plus Kit
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
VaPro (Tiemann/Coude)
VaPro Pocket (Tiemann/Coude)
VaPro Plus
Apogee Plus
InstantCath Protect
LOOP OSTOMY BRIDGE
BEDSIDE URINE COLLECTOR
Vented Leg Bag
VaPro Pocket (40cm/16 inch)
VaPro Pocket (20cm/8 inch)
HOLLISTER
HOLLISTER STOMA BAGS
HOLLISTER DRAINING WOUND MANAGEMENT
STOMA BAGS
Adapt
Restore
Apogee IC
TRE
CeraPlus
Premium
Nova 1
HolliHesive
Karaya
Onli (LCC)
InstantCath
ADAPT
PREMIUM
KARAYA
Vertical Drain/Tube Attachment Device
Deluxe Urinary Leg Bag Straps
Extension Tubing with connector
ModermaFlex
VaPro Plus Pocket (20cm/8 inch)
VaPro
Urinary Night Drainage Bags
InView
Male Incontinence Sheath/Catheter, Self Adhesive
Extended Wear
Everyday
VaPro Plus Pocket (40cm/16 inch)
AnchorFast
AnchorFast Guard Select
AnchorFast SlimFit
AnchorFast Guard
Suavita
Pouchkins
Hollister Solo
Holligard
Fecal Collectors
DuoSoft
m9
Novalife 1
Advance
Advance Plus Pocket
Advance Plus
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device