New Image

Basic Information

• Brand Name: New Image
• Primary DI: 00610075114146
• Version / Model: 19156
• Catalog Number: 19156
• Company Name: HOLLISTER INCORPORATED
• Labeler DUNS: 005527098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2022-11-02
• Public Version Status: Update
• Public Device Record Key: ccf79b69-ea63-4689-b066-feb65561c045

Device Description

Colostomy/Ileostomy Kit,FlexWear

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PQE	Ostomy care kit	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62525	Intestinal ostomy bag/support kit	A collection of devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure). It includes not only the intestinal ostomy bag and a base plate, but also additional ostomy fitting/maintenance supportive devices (e.g., towels, wipes, scissors). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20610075114140	GS1	CAS	6	In Commercial Distribution
Primary	00610075114146	GS1
Unit of Use	00610075110445	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	89	Millimeter
Lumen/Inner Diameter	102	Millimeter