andorate® Biopsy Irrigator

GUDID 14897106953896

GA Health Company Limited

Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use

• Primary Device ID: 14897106953896
• NIH Device Record Key: 7ff665f8-f79c-475d-9139-07474f2e658a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: andorate® Biopsy Irrigator
• Version Model Number: GAR015
• 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: 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	04897106953899 [Primary]
GS1	14897106953896 [Package]; Contains: 04897106953899; Package: Box [100 Units]; In Commercial Distribution
GS1	24897106953893 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Product Code

• ODC: Endoscope Channel Accessory

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: 2022-02-07
• Device Publish Date: 2022-01-28

Devices Manufactured by GA Health Company Limited

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• 14897106955814 - andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit: 2023-10-12
• 14897106955821 - andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit: 2023-10-12
• 14897106955838 - andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit: 2023-10-12
• 14897106955869 - andorate® CO2 Source Tubing Adapter: 2023-09-07
• 14897106955852 - andorate® CO2 Source Tubing Adapter: 2023-09-05