andorate® 2-piece Valve Kit

GUDID 04897106953363

GA Health Company Limited

Endoscope channel support kit

• Primary Device ID: 04897106953363
• NIH Device Record Key: 75c621d7-dc17-4ed2-a261-72318ed9040e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: andorate® 2-piece Valve Kit
• Version Model Number: GAR109
• 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	04897106953363 [Primary]
GS1	14897106953360 [Package]; Package: Box [50 Units]; In Commercial Distribution
GS1	24897106953367 [Package]; Contains: 14897106953360; Package: Carton [4 Units]; In Commercial Distribution

FDA Product Code

• KTI: Bronchoscope 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: 2024-10-14
• Device Publish Date: 2024-10-04

On-Brand Devices [andorate® 2-piece Valve Kit]

• 14897106953889: GAR004C
• 14897106954039: GAR037C
• 14897106953834: GAR087C
• 04897106953363: GAR109