andorate® Air/Water Bottle Tubing with Side Port

GUDID 14897106950109

GA Health Company Limited

Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use

• Primary Device ID: 14897106950109
• NIH Device Record Key: 28f4e7e0-4be3-4bcb-8608-700d6d68a51b
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04897106950102 [Primary]
GS1	14897106950109 [Package]; Contains: 04897106950102; Package: Box [10 Units]; In Commercial Distribution
GS1	24897106950106 [Package]; Package: Carton [4 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2020-05-28

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• 14897106955821 - andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit: 2023-10-12
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• 14897106955852 - andorate® CO2 Source Tubing Adapter: 2023-09-05