Premier

Basic Information

• Brand Name: Premier
• Primary DI: 00610075106561
• Version / Model: 82125
• Catalog Number: 82125
• Company Name: HOLLISTER INCORPORATED
• Labeler DUNS: 005527098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2018-12-01
• Public Version: 2
• Public Version Date: 2022-11-02
• Public Version Status: Update
• Public Device Record Key: 2f4a7a79-cc90-4e22-b8c2-337c3c4a3f31

Device Description

1-Piece Closed Ostomy Pouch, SoftFlex

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
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
Package	20610075106565	GS1	CAS	12	In Commercial Distribution
Primary	00610075106561	GS1
Unit of Use	30610075106562	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	25	Millimeter