Sage Fecal Management System

Basic Information

• Brand Name: Sage Fecal Management System
• Primary DI: 00618029980052
• Version / Model: 700-118
• Catalog Number: 700-118
• Company Name: SAGE PRODUCTS, LLC
• Labeler DUNS: 054326178
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-15
• Public Version: 2
• Public Version Date: 2023-01-12
• Public Version Status: Update
• Public Device Record Key: c66e24db-dbbc-4212-97f9-3b7213ee3c09
• Distribution End Date: 2022-10-31

Device Description

Sage Fecal Management System

Device Characteristics

• Single Use: Yes
• 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: No
• 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
62038	Faecal incontinence collector, skin-fixation	A device intended to be used for the collection of liquid or semi-liquid stool (faeces) from a patient who is unable to control stool discharge. It may be in the form of a collection bag/pouch which attaches to the skin around the anus (e.g., via an adhesive hydrocolloid wafer), or an external catheter-like tube intended to noninvasively attach to the perianal skin (e.g., via a flange) to drain faecal matter to an attached pouch; it typically has a flushing and/or drainage port. It is made of soft plastic materials and may have deodorizing capability. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50618029980057	GS1	case	10	Not in Commercial Distribution	2022-10-31
Primary	00618029980052	GS1

Customer Contacts

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