ESTEEM+

Basic Information

• Brand Name: ESTEEM+
• Primary DI: 00768455153169
• Version / Model: 421848
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-09-29
• Public Version: 2
• Public Version Date: 2023-05-19
• Public Version Status: Update
• Public Device Record Key: 76b7cd7d-aa97-4198-9adf-888600f032f5

Device Description

Esteem®+ One-Piece Drainable Cut-To-Fit, Clipped, Modified Stomahesive® With Filter, 1 Comfort Panel,Standard 12", Transparent 13/16-2 3/4", 20-70Mm

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
EXH	BAG, URINARY, ILEOSTOMY	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	10768455153166	GS1		14	In Commercial Distribution
Primary	00768455153169	GS1
Unit of Use	00768455172580	GS1

Customer Contacts

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