AVANTGARDE

Basic Information

• Brand Name: AVANTGARDE
• Primary DI: 05060182172112
• Version / Model: AVG200
• Company Name: PROSYS INTERNATIONAL LIMITED
• Labeler DUNS: 221836112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-10-20
• Public Version: 1
• Public Version Date: 2023-10-30
• Public Version Status: New
• Public Device Record Key: 222aa0de-93dd-4c7c-ae59-1351d36bbb75

Device Description

Fecal Collection Bag

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66820	Faecal collection toilet bag	A sheet of dissolvable polymer intended to be attached to a toilet seat to form a hanging receptacle to directly receive and hold stool, enabling a sample to be collected. It can thereafter be flushed down the toilet. This is a single use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	15060182171556	GS1
Primary	05060182172112	GS1

Premarket Submissions

Submission Number	Supplement Number
K193325	000