Andorate® Single Chamber Polyp Trap

GUDID 14897106950543

GA Health Company Limited

Surgical suction system collection container, single-use

• Primary Device ID: 14897106950543
• NIH Device Record Key: d95deded-67b4-4959-849a-f4e1ad4537e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Andorate® Single Chamber Polyp Trap
• Version Model Number: GAR014
• Company DUNS: 686908512
• Company Name: GA Health Company Limited
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	04897106950546 [Primary]
GS1	14897106950543 [Package]; Contains: 04897106950546; Package: Box [50 Units]; In Commercial Distribution
GS1	24897106950540 [Package]; Contains: 04897106950546; Package: Carton [300 Units]; In Commercial Distribution

FDA Product Code

• CBC: Bottle, Collection And Trap, Breathing System (Uncalibrated)

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: 2020-08-25
• Device Publish Date: 2020-08-17

Devices Manufactured by GA Health Company Limited

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• 04897106953363 - andorate® 2-piece Valve Kit: 2024-10-14
• 14897106954626 - andorate® Suction Valve: 2024-10-14
• 14897106955166 - andorate® Biopsy Valve: 2024-10-14
• 14897106955562 - andorate® Champion 4-piece valve kit: 2024-10-14
• 14897106955579 - andorate® Champion 3-piece valve kit: 2024-10-14
• 14897106955616 - andorate® Champion 3-piece valve kit: 2024-10-14
• 14897106955647 - andorate® Champion 4-piece valve kit: 2024-10-14