ESTEEM+

Basic Information

• Brand Name: ESTEEM+
• Primary DI: 00768455111749
• Version / Model: 416704
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2022-09-28
• Public Version: 1
• Public Version Date: 2022-10-06
• Public Version Status: New
• Public Device Record Key: e2fa3e30-445a-4e2c-bd2d-b9e780159c35

Device Description

Esteem®+ One-Piece Pre-Cut Closed-End Pouch, Modified Stomahesive, Filter, One-Sided Comfort Panel, 8" Opaque, 1" (25Mm)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZQ	POUCH, COLOSTOMY	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	10768455111746	GS1		6	In Commercial Distribution
Primary	00768455111749	GS1
Unit of Use	00768455188215	GS1

Customer Contacts

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