ESTEEM+

Basic Information

• Brand Name: ESTEEM+
• Primary DI: 00768455115877
• Version / Model: 416916
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2019-04-12
• Public Version: 6
• Public Version Date: 2023-08-01
• Public Version Status: Update
• Public Device Record Key: 0cd633c3-02a6-46b3-b88d-9705cc8407b5
• Distribution End Date: 2023-02-26

Device Description

Post Op Kit Sterile: Esteem® One-Piece Drainable, 4" (100Mm), Transparent, Standard With Invisiclose® Tail Closure, With Stomahesive® Cut-To-Fit

Device Characteristics

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31075	One-piece intestinal ostomy bag, open-ended	A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of in accordance with the clinician's instructions. The distal end of the pouch can be opened for drainage of the waste (average of 400-800 ml per day) and emptied several times per day. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10768455115874	GS1	Case	5	Not in Commercial Distribution	2023-02-26
Primary	00768455115877	GS1
Unit of Use	00768455188826	GS1

Customer Contacts

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