CONVATEC

Basic Information

• Brand Name: CONVATEC
• Primary DI: 00768455107186
• Version / Model: 175507
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-22
• Public Version: 6
• Public Version Date: 2023-07-21
• Public Version Status: Update
• Public Device Record Key: dbd2c369-cb18-4c43-9cb7-1b7eebffc970

Device Description

Ostomy Appliance Belt, Adjustable, 42 Mm

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
EXB	Collector, Ostomy	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62951	Ostomy appliance belt	An adjustable and/or elastic, strip-like device intended to secure an ostomy appliance [e.g., bag, irrigation sleeve] (not included) to a patient’s stoma (e.g., in the intestine/colon) during use. The appliance is attached to the device which is worn by the patient; the device does not include an attachment flange, plate, or ring and is not intended to protect the ostomy site or appliance (i.e., does not include a shield). It is typically made of synthetic polymer materials and is intended for use in the home and healthcare facility. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10768455107183	GS1	Case	12	In Commercial Distribution
Primary	00768455107186	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	107	Centimeter