Protego Air Water Bottle Tubing with CO2 Extend

GUDID 14897106955968

GA Health Company Limited

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 14897106955968
• NIH Device Record Key: c0bf2a66-a294-4d9c-b539-250b0af7ca2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protego Air Water Bottle Tubing with CO2 Extend
• Version Model Number: 202002CO2EXTUS
• 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	04897106955961 [Primary]
GS1	14897106955968 [Package]; Contains: 04897106955961; Package: Box [10 Units]; In Commercial Distribution
GS1	24897106955965 [Package]; Package: Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231602

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: 2025-08-07
• Device Publish Date: 2025-07-30

On-Brand Devices [Protego Air Water Bottle Tubing with CO2 Extend ]

• 14897106955968: 202002CO2EXTUS
• 14897106955333: 202001CO2EXTUS