andorate® Biopsy Valve

GUDID 14897106954008

GA Health Company Limited

Endoscopic biopsy valve, single-use

• Primary Device ID: 14897106954008
• NIH Device Record Key: be0549d6-83dd-41f0-aaa4-8d1f964082ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: andorate® Biopsy Valve
• Version Model Number: GAR018-S
• 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	04897106954001 [Primary]
GS1	14897106954008 [Package]; Contains: 04897106954001; Package: Box [100 Units]; In Commercial Distribution
GS1	24897106954005 [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: 2022-01-18
• Device Publish Date: 2022-01-10

On-Brand Devices [andorate® Biopsy Valve]

• 14897106953698: GAR018P
• 14897106953711: GABV-02
• 14897106953704: GAR028
• 14897106953681: GAR018
• 14897106953476: GABV-01
• 14897106954008: GAR018-S
• 14897106953902: GAR018P-S
• 14897106953759: GAR028-S
• 14897106955166: GAR021