3-piece valve kit (Suction, Air/Water and Biopsy Valves)

GUDID 14897106951090

GA Health Company Limited

Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit Endoscope channel support kit

• Primary Device ID: 14897106951090
• NIH Device Record Key: bfae628d-302a-45c6-9c26-c8c24ddad421
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3-piece valve kit (Suction, Air/Water and Biopsy Valves)
• Version Model Number: EN10229
• Company DUNS: 686908512
• Company Name: GA Health Company Limited
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04897106951093 [Primary]
GS1	14897106951090 [Package]; Contains: 04897106951093; Package: Box [50 Units]; In Commercial Distribution
GS1	24897106951097 [Package]; Package: Carton [4 Units]; In Commercial Distribution

FDA Product Code

• ODC: Endoscope Channel Accessory

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-03-23
• Device Publish Date: 2022-04-11

Devices Manufactured by GA Health Company Limited

• 14897106955784 - andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit: 2023-10-12
• 14897106955791 - andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit: 2023-10-12
• 14897106955807 - andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit: 2023-10-12
• 14897106955814 - andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit: 2023-10-12
• 14897106955821 - andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit: 2023-10-12
• 14897106955838 - andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit: 2023-10-12
• 14897106955869 - andorate® CO2 Source Tubing Adapter: 2023-09-07
• 14897106955852 - andorate® CO2 Source Tubing Adapter: 2023-09-05