Hollister

Basic Information

• Brand Name: Hollister
• Primary DI: 00610075071999
• Version / Model: 5551
• Catalog Number: 5551
• Company Name: HOLLISTER INCORPORATED
• Labeler DUNS: 005527098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-12-01
• Public Version: 1
• Public Version Date: 2022-12-09
• Public Version Status: New
• Public Device Record Key: 31a9fd87-b1fc-406a-930d-303c8afa2b97

Device Description

High Output Collection Bag

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXB	COLLECTOR, OSTOMY	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61373	Ostomy bag extension	A plastic pouch intended to function as an extension to a urostomy or intestinal ostomy bag to increase the collection volume capacity of discharged excreta (urine or faeces) from a patient, typically during sleep. It is designed to connect to the urostomy/intestinal ostomy bag, not directly to the patient, and typically has a drainage tap to permit the emptying of urine/faeces; a non-wearable bag hanger/holder may be included with the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10610075071996	GS1	CAS	1	In Commercial Distribution
Primary	00610075071999	GS1
Unit of Use	00610075090754	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	2000	Milliliter