Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2320961

FEI Number

3003172243

Entity Name

HOLLISTER, INC.

City/State/Country

Mount Juliet, TN, US

Establishment Address

12011 VOLUNTEER BLVD, Mount Juliet, TN 37122, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Hollister Inc. (Owner Number: 1480288)

Owner / Operator Contact Address

2000 HOLLISTER DR., --, Libertyville, IL 60048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Hollister 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 Hollister Female Urinary Pouch Male Urinary Pouch Vertical Drain/Tube Attachment Device VaPro Plus Pocket (40cm/16 inch) Hollister New Image Nova Conform 2 Premier ModermaFlex LOOP OSTOMY BRIDGE New Image Hollister HOLLISTER HOLLISTER STOMA BAGS HOLLISTER DRAINING WOUND MANAGEMENT STOMA BAGS Adapt Securi-T USA Restore Infyna Chic Onli (LCC) AnchorFast AnchorFast Guard Select AnchorFast SlimFit AnchorFast Guard Hollister Restore Deluxe Urinary Leg Bag Straps Leg Bag Straps Extension Tubing with connector Securi-T USA Adapt VaPro Pocket VaPro Plus Pocket Adapt Hollister Apogee Catheter Insertion Kit VaPro Pocket Plus Kit Urinary Leg Bag BEDSIDE URINE COLLECTOR Hollister Vented Leg Bag Securi-T USA TRE Dansac Hollister CeraPlus Nova 2 Premium Adapt NovaLife 1 GX+ Nova 1 HolliHesive NovaLife Invent NovaLife 2 GX+ NovaLife 2 Nova Karaya NovaLife 1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-09-27
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2006-10-17
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	1992-07-21
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2007-11-30
NOA	Device, Paste-On For Incontinence, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-09-27
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2006-05-24
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2019-10-16
PQE	Ostomy Care Kit	Gastroenterology, Urology	Class 1	876.5900	2022-07-14
EZP	Rod, Colostomy	Gastroenterology, Urology	Class 2	876.4270	2006-10-16
EXD	Irrigator, Ostomy	Gastroenterology, Urology	Class 2	876.5895	1992-07-21
GDS	Bag, Stomal	Gastroenterology, Urology	Class 1	876.5900	1992-07-21
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2015-01-28
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2001-08-01
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2022-09-14
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2022-04-12
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	1996-06-14
FOB	Bedpan	General Hospital	Class 1	880.6730	2006-10-17
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2007-11-30
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2017-03-23
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2016-03-08
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2020-01-16
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2017-03-06
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2006-05-24
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2010-02-06
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	1995-04-19
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2006-09-27

Official Correspondent

Sofia Abreu Read

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hollister Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016675012	Hollister Lietuva UAB	Kaunas district, LT
9616668	HOLLISTER ULC	REHINS BALLINA Mayo, IE
1119193	HOLLISTER INCORPORATED	STUARTS DRAFT, VA, US
3014404707	Hollister Services BV	Roosendaal Noord-Brabant, NL
1480288	HOLLISTER INCORPORATED	LIBERTYVILLE, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2320961. Last updated year: 2026. Please use registration number 2320961 when referencing this establishment in official correspondence.