Andorate® 4-piece Valve Kit

GUDID 14897106950260

GA Health Company Limited

Endoscope channel support kit

• Primary Device ID: 14897106950260
• NIH Device Record Key: 89d96723-f057-471e-8348-1a8b1047a304
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Andorate® 4-piece Valve Kit
• Version Model Number: GAR046
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04897106950263 [Primary]
GS1	14897106950260 [Package]; Contains: 04897106950263; Package: Box [50 Units]; In Commercial Distribution
GS1	24897106950267 [Package]; Package: Carton [4 Units]; In Commercial Distribution

FDA Product Code

• ODX: Autonomous Extracorporeal Blood Leak Detector/Alarm

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-01-07
• Device Publish Date: 2020-05-28

On-Brand Devices [Andorate® 4-piece Valve Kit]

• 14897106950451: GAR092
• 14897106950260: GAR046
• 14897106953926: GAR066
• 14897106953766: GAR081
• 14897106954077: GAR081P
• 14897106953773: GAR092