New Image 19153

GUDID 20610075036473

Colostomy/Ileostomy Kit,FlexWear

HOLLISTER INCORPORATED

Intestinal ostomy bag/support kit
Primary Device ID20610075036473
NIH Device Record Keya56d697a-711c-411c-8788-ba857aef11be
Commercial Distribution StatusIn Commercial Distribution
Brand NameNew Image
Version Model Number19153
Catalog Number19153
Company DUNS005527098
Company NameHOLLISTER INCORPORATED
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com
Phone+1(800)323-4060
Emailcs@hollister.com

Device Dimensions

Lumen/Inner Diameter57 Millimeter
Lumen/Inner Diameter44 Millimeter
Lumen/Inner Diameter57 Millimeter
Lumen/Inner Diameter44 Millimeter
Lumen/Inner Diameter57 Millimeter
Lumen/Inner Diameter44 Millimeter
Lumen/Inner Diameter57 Millimeter
Lumen/Inner Diameter44 Millimeter
Lumen/Inner Diameter57 Millimeter
Lumen/Inner Diameter44 Millimeter
Lumen/Inner Diameter57 Millimeter
Lumen/Inner Diameter44 Millimeter
Lumen/Inner Diameter57 Millimeter
Lumen/Inner Diameter44 Millimeter
Lumen/Inner Diameter57 Millimeter
Lumen/Inner Diameter44 Millimeter
Lumen/Inner Diameter57 Millimeter
Lumen/Inner Diameter44 Millimeter
Lumen/Inner Diameter57 Millimeter
Lumen/Inner Diameter44 Millimeter
Lumen/Inner Diameter57 Millimeter
Lumen/Inner Diameter44 Millimeter
Lumen/Inner Diameter57 Millimeter
Lumen/Inner Diameter44 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100610075114924 [Unit of Use]
GS110610075114129 [Primary]
GS120610075036473 [Package]
Contains: 10610075114129
Package: CAS [6 Units]
In Commercial Distribution

FDA Product Code

PQEOstomy care kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-09
Device Publish Date2022-12-01

On-Brand Devices [New Image]

10610075115041Two-Piece Mini Drainable Pre-sized Pouch, with Filter, Lock 'n Roll closure, Transparent, 70 mm,
20610075114140Sterile Kit with Drainable Pouch, Clamp Closure, Loop Ostomy Bridge
20610075114119Sterile Kit with Drainable Pouch, Lock 'n Roll Closure, Loop Ostomy Bridge
20610075114089Non-sterile Kit with Drainable Pouch, Clamp Closure, Loop Ostomy Bridge
20610075114058Non-sterile Kit with Drainable Pouch, Lock 'n Roll Closure, Loop Ostomy Bridge
20610075198638Urostomy Kit, Flextend
20610075198621Colostomy/Ileostomy Kit, FlexWear
20610075198614Colostomy/Ileostomy Kit, FlexWear
20610075186321Urostomy Kit, FormaFlex
20610075186307Urostomy Kit, FormaFlex
20610075186284Colostomy/Ileostomy Kit,FormaFlex
20610075186260Colostomy/Ileostomy Kit,FormaFlex
20610075036572Urostomy Kit, Flextend
20610075036466Colostomy/Ileostomy Kit,FlexWear
20610075036244Colostomy/Ileostomy Kit,FlexWear
20610075132342Urostomy Kit, Flextend
20610075036282Colostomy/Ileostomy Kit, FlexWear
20610075036206Colostomy/Ileostomy Kit, FlexWear
206100751147442-Piece Drainable Ostomy Pouch with Soft Tap
20610075036565Urostomy Kit, Flextend
20610075036558Urostomy Kit, Flextend
20610075036534Urostomy Kit, Flextend
20610075036527Urostomy Kit, Flextend
20610075036503Colostomy/Ileostomy Kit,FlexWear
20610075036473Colostomy/Ileostomy Kit,FlexWear
20610075036268Colostomy/Ileostomy Kit,FlexWear
20610075036251Colostomy/Ileostomy Kit,FlexWear
20610075036404Colostomy/Ileostomy Kit, FlexWear
20610075036299Colostomy/Ileostomy Kit, FlexWear
20610075036220Colostomy/Ileostomy Kit, FlexWear
20610075036213Colostomy/Ileostomy Kit, FlexWear
206100751879772-Piece Urostomy Pouch
206100751879602-Piece Urostomy Pouch
206100751879532-Piece Urostomy Pouch
206100751879462-Piece Urostomy Pouch
206100751879392-Piece Urostomy Pouch
206100751879222-Piece Urostomy Pouch
206100751879152-Piece Urostomy Pouch
206100751879082-Piece Urostomy Pouch
206100751878922-Piece Urostomy Pouch
206100751841432-Piece Urostomy Pouch
206100751841362-Piece Urostomy Pouch
206100751841292-Piece Urostomy Pouch
206100751840442-Piece Urostomy Pouch
206100751840372-Piece Urostomy Pouch
206100751840202-Piece Urostomy Pouch
206100751820402-Piece Drainable Ostomy Pouch
206100751820332-Piece Drainable Ostomy Pouch
206100751820262-Piece Drainable Ostomy Pouch
206100751819442-Piece Drainable Ostomy Pouch

Trademark Results [New Image]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEW IMAGE
NEW IMAGE
90479589 not registered Live/Pending
NEW IMAGE CAR CLUB
2021-01-21
NEW IMAGE
NEW IMAGE
79225985 not registered Dead/Abandoned
High Street TV (Group) Ltd.
2017-11-27
NEW IMAGE
NEW IMAGE
79225759 5516335 Live/Registered
High Street TV (Group) Ltd
2017-11-27
NEW IMAGE
NEW IMAGE
78853649 not registered Dead/Abandoned
BEAUTY HOLDING LLC
2006-04-04
NEW IMAGE
NEW IMAGE
78705781 3202942 Dead/Cancelled
B.S.G.H. Company, Inc.
2005-09-01
NEW IMAGE
NEW IMAGE
77349881 not registered Dead/Abandoned
First Lady International Corporation
2007-12-12
NEW IMAGE
NEW IMAGE
77162753 3755086 Live/Registered
Beauty Holding LLC
2007-04-23
NEW IMAGE
NEW IMAGE
76567539 not registered Dead/Abandoned
First Lady International Corp.
2003-12-17
NEW IMAGE
NEW IMAGE
76413934 not registered Dead/Abandoned
SHEIBANI-RAD, S. SHANE
2002-05-23
NEW IMAGE
NEW IMAGE
75781647 2383040 Dead/Cancelled
Fibre-Metal Products Co., The
1999-08-23
NEW IMAGE
NEW IMAGE
75410331 2298811 Live/Registered
Hollister Incorporated
1997-12-23
NEW IMAGE
NEW IMAGE
75372118 2278805 Dead/Cancelled
GENDEX CORP.
1997-10-14
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.