Karaya 5

Basic Information

• Brand Name: Karaya 5
• Primary DI: 00610075033249
• Version / Model: 3324
• Catalog Number: 3324
• Company Name: HOLLISTER INCORPORATED
• Labeler DUNS: 005527098
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2022-12-01
• Public Version: 2
• Public Version Date: 2025-06-03
• Public Version Status: Update
• Public Device Record Key: 3153a32c-f597-4cd1-93a3-1a3c527329ae
• Distribution End Date: 2025-05-30

Device Description

1-Piece Closed Ostomy Pouch, Convex

Device Characteristics

• Single Use: Yes
• 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
31066	One-piece intestinal ostomy bag, closed-ended	A plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of when full. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00610075033249	GS1
Unit of Use	00610075083206	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	38	Millimeter