andorate® Champion 4-piece valve kit

Basic Information

• Brand Name: andorate® Champion 4-piece valve kit
• Primary DI: 04897106955565
• Version / Model: 101092
• Company Name: GA Health Company Limited
• Labeler DUNS: 686908512
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-04
• Public Version: 2
• Public Version Date: 2026-02-06
• Public Version Status: Update
• Public Device Record Key: 9e7e1515-76dc-4b82-b114-4da11e6be3ea
• Distribution End Date: 2026-01-12

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	876.1500	2
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	876.1500	2

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
Package	14897106955562	GS1	Box	50	Not in Commercial Distribution	2026-01-12
Primary	04897106955565	GS1
Package	24897106955569	GS1	Carton	4	Not in Commercial Distribution	2026-01-12