andorate® Air/Water Bottle Tubing with Side Port

GUDID 14897106954930

GA Health Company Limited

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 14897106954930
• NIH Device Record Key: 2d2edd7f-fca5-48ae-93f0-b7c9f5d91210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: andorate® Air/Water Bottle Tubing with Side Port
• Version Model Number: GAR076US
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04897106954933 [Primary]
GS1	14897106954930 [Package]; Contains: 04897106954933; Package: Box [20 Units]; In Commercial Distribution
GS1	24897106954937 [Package]; Package: Carton [2 Units]; In Commercial Distribution

FDA Product Code

• OCX: Endoscopic Irrigation/Suction System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-21
• Device Publish Date: 2022-01-13

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• 14897106955494 - Protego Hybrid Tubing with CO2 Extend: 2025-08-07