AWCduo

Basic Information

• Brand Name: AWCduo
• Primary DI: 04260206311911
• Version / Model: 124 cm
• Catalog Number: 200.57.05
• Company Name: Ovesco Endoscopy AG
• Labeler DUNS: 344007369
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-05
• Public Version: 1
• Public Version Date: 2025-06-13
• Public Version Status: New
• Public Device Record Key: c3c0201a-5ea6-494d-bd46-45fd31779da2

Device Description

The AWCduo is an additional working channel for flexible endoscopes • external channel for insertion of instruments or flushing and suction • it consists of: flexible cap (for endoscope diameters from 9.8 mm to 11.5 mm) | AWCduo working channel with connector and valve with Luer Lock connection | AWCduo mounting clasp with fastening strap for fixation at the endoscope handle | endoscope sleeve | adhesive tapes for fixation • for gastroscopes with insertion length of 103 - 110 cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• 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
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60760	Endoscope channel support kit	A collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260206311911	GS1
Package	04260206311904	GS1	Folding box	2	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			for instruments with max. diameter of 3.2 mm
Device Size Text, specify			for endoscopes with diameter 9.8 - 11.5 mm
Device Size Text, specify			working length 124 cm