Question 1

What types of medical devices does GA Health Company Limited manufacture?

Accepted Answer

GA Health Company Limited specializes in accessories for endoscopic procedures. Their product range includes single-use and reusable items like insufflation tubing sets (both single-use and reusable), endoscope channel support kits, and cleaning utensils. They also produce disposable components such as suction valves, tourniquets, biopsy port adapters, and reusable surgical instrument accessories. Additional offerings include CO₂ tubing adapters, air/water bottle tubing extensions, and protective eyewear designed specifically for endoscopic use.

Question 2

Where is GA Health Company Limited based, and what regulatory database lists its devices?

Accepted Answer

GA Health Company Limited is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which serves as a centralized registry for tracking medical devices authorized for use in the U.S. This database helps ensure transparency and traceability of their products.

Question 3

How are the devices manufactured by GA Health Company Limited classified under FDA regulations?

Accepted Answer

The devices produced by GA Health Company Limited fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and benefits, as outlined in FDA regulations.

Question 4

What is the purpose of the single-use and reusable accessories produced by GA Health Company Limited?

Accepted Answer

The single-use accessories, such as insufflation tubing sets, suction valves, and tourniquets, are designed for one-time use to reduce infection risks and ensure hygiene in endoscopic procedures. Reusable accessories, like endoscope cleaning utensils and certain tubing sets, are engineered for durability and repeated sterilization, providing cost-effective solutions for healthcare settings. Both categories enhance procedural efficiency and safety by supporting proper handling and maintenance of endoscopic equipment.

Device	Model / Reference	Registries	Class	Status
andorate® Air/Water Bottle Tubing	GAR090US	FDA UDI	Class II	Unknown
andorate® Disposable Endoscope Valves Set	GAR081	FDA UDI	Class II	Unknown
andorate® Disposable Endoscope Valves Set	GAR004C	FDA UDI	Class II	Unknown
andorate® Eye Cornea Protectors	GAR001	FDA UDI	Class I	Unknown
andorate® Suction Channel Cleaning Adapter	GAR075	FDA UDI	Class I	Unknown
andorate® A/W Channel Cleaning Adapter + 3-piece Valve Kit	GAR3865	FDA UDI	Class II	Unknown
andorate® Single-End Tapered Brush	SDPC0198	FDA UDI	Class I	Unknown
Protego Air Water Bottle Tubing with CO2 Extend	202001CO2EXTUS	FDA UDI	Class II	Active
andorate® Air/Water Channel Cleaning Adapter	GAR105	FDA UDI	Class I	Unknown
andorate® 2-piece Cleaning Adapter Kit	GAR3875-NS	FDA UDI	Class I	Unknown
Protego Air Water Bottle Tubing with CO2 Extend	202002CO2EXTUS	FDA UDI	Class II	Active
andorate® Disposable Endoscope Valves Set	GAR004	FDA UDI	Class II	Unknown
STOPCON Biopsy Valve For Pentax® GI-Endoscope	EN10234B	FDA UDI	Class II	Active
andorate® Single Use Tourniquet	GAR022	FDA UDI	Class I	Active
andorate® CO2 Source Tubing Adapter	GAR093	FDA UDI	Class I	Active
Air/Water Bottle Tubing with CO2 Extend (for US Market)	EN10922B	FDA UDI	Class II	Active
andorate® A/W Channel Cleaning Adapter + 4-piece Valve Kit	GAR105092	FDA UDI	Class I	Unknown
Andorate® Single Chamber Polyp Trap	GAR014	FDA UDI	Class II	Unknown
STOPCON Disposable Endoscope Valves Set	EN10229PB	FDA UDI	Class II	Active
andorate® A/W Channel Cleaning Adapter + 4-piece Valve Kit	GAR3846	FDA UDI	Class II	Unknown
CO2 Source Tubing Adapter (Non-Sterile)	EN10919	FDA UDI	Class I	Active
andorate® Click4Catch™ Click into Place Polyp Trap with Four Removable Capture C	GAR082	FDA UDI	Class II	Unknown
andorate® 2-piece Cleaning Adapter Kit	GAR3875	FDA UDI	Class I	Unknown
Auxiliary Water Connector	EN10906	FDA UDI	Class II	Active
andorate® Champion 4-piece valve kit	101081	FDA UDI	Class II	Active
andorate® Eye Cornea Protectors	GAR001-NP	FDA UDI	Class I	Active
Biopsy Port Cleaning Adapter	GAR075-S	FDA UDI	Class I	Active
andorate® Biopsy Valve	GAR018P	FDA UDI	Class II	Active
Air/Water Valve	EN10230	FDA UDI	Class II	Active
andorate® Bite Block 66Fr with Strap and Tooth Protector	SDPC0210F	FDA UDI	Class I	Unknown
andorate® Disposable Endoscope Valves Set	GAR065	FDA UDI	Class II	Unknown
andorate® Champion 3-piece valve kit	101065	FDA UDI	Class II	Active
Andorate Cleaning Brushes	SDPC0197	FDA UDI	Class I	Unknown
Protego Air Water Connector	201002	FDA UDI	Class II	Active
Andorate PearlCatch Single Chamber Polyp Trap	GAR014	FDA UDI	Class II	Unknown
andorate® A/W Channel Cleaning Adapter + 4-piece Valve Kit	GAR105092	FDA UDI	Class I	Unknown
andorate® Suction Valve	GAR087A	FDA UDI	Class II	Active
andorate® A/W Channel Cleaning Adapter + 3-piece Valve Kit	GAR105087	FDA UDI	Class I	Unknown
Air/Water Channel Cleaning Adapter	GAR301001-S	FDA UDI	Class I	Active
Andorate® Air/Water Channel Cleaning Adapter	GAR038	FDA UDI	Class I	Unknown
andorate® 4-piece Valve Kit	GAR092	FDA UDI	Class II	Unknown
andorate® A/W Channel Cleaning Adapter + 3-piece Valve Kit	GAR3804	FDA UDI	Class II	Unknown
Air Water Channel Cleaning Adapter + Champion 4-piece Valve Kit	101094	FDA UDI	Class II	Active
andorate® Bite Block 55.5Fr with Strap	SDPC0209A	FDA UDI	Class I	Unknown
Protego Air Water Bottle Tubing	202002US	FDA UDI	Class II	Active
Single Chamber Polyp Trap (Non-sterile)	EN10113.1	FDA UDI	Class II	Active
Protego Air Water Connector	201003	FDA UDI	Class II	Active
andorate® Champion 4-piece valve kit	101046	FDA UDI	Class II	Active
Andorate Four-Chamber Polyp Trap	GAR023	FDA UDI	Class II	Unknown
andorate® Suction Channel Cleaning Adapter	GAR075	FDA UDI	Class I	Unknown

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