andorate® CO2 Extend Tubing with Luer Connector

GUDID 14897106953797

GA Health Company Limited

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 14897106953797
• NIH Device Record Key: c030db06-9755-4dc2-917f-f6079d43a4fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: andorate® CO2 Extend Tubing with Luer Connector
• Version Model Number: GAR091
• 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	04897106953790 [Primary]
GS1	14897106953797 [Package]; Contains: 04897106953790; Package: Box [20 Units]; In Commercial Distribution
GS1	24897106953794 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200388

FDA Product Code

• FCX: Insufflator, Automatic Carbon-Dioxide For Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-03
• Device Publish Date: 2022-02-23

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