vacutore® CO2 Extend Tubing with Luer Connector

GUDID 14897106950208

GA Health Company Limited

Endoscopic insufflation tubing set, sterile, reusable

• Primary Device ID: 14897106950208
• NIH Device Record Key: 7ce1bfa7-1126-486b-aa32-e00bdf985352
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: vacutore® 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	04897106950201 [Primary]
GS1	14897106950208 [Package]; Contains: 04897106950201; Package: Box [20 Units]; In Commercial Distribution
GS1	24897106950205 [Package]; Contains: 04897106950201; Package: Cartoon [200 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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-22
• Device Publish Date: 2021-03-12

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