andorate® 4-piece Valve Kit

Basic Information

• Brand Name: andorate® 4-piece Valve Kit
• Primary DI: 04897106954070
• Version / Model: GAR081P
• Company Name: GA Health Company Limited
• Labeler DUNS: 686908512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-23
• Public Version: 1
• Public Version Date: 2022-03-03
• Public Version Status: New
• Public Device Record Key: 8bae830a-d7ad-4140-8ab9-5db476e0d7f8

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	14897106954077	GS1	Box	50	In Commercial Distribution
Primary	04897106954070	GS1
Package	24897106954074	GS1	Carton	4	In Commercial Distribution