andorate® Disposable Endoscope Valves Set

GUDID 04897106950355

GA Health Company Limited

Endoscope channel support kit

• Primary Device ID: 04897106950355
• NIH Device Record Key: d6939a83-90b1-468b-8d8c-01fddeb4f0aa
• Commercial Distribution Discontinuation: 2021-07-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: andorate® Disposable Endoscope Valves Set
• Version Model Number: GAR081
• 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	04897106950355 [Primary]
GS1	14897106950352 [Package]; Package: Box [50 Units]; Discontinued: 2021-07-01; Not in Commercial Distribution
GS1	24897106950359 [Package]; Contains: 14897106950352; Package: Carton [4 Units]; Discontinued: 2021-07-01; Not in Commercial Distribution

FDA Product Code

• OCX: Endoscopic Irrigation/Suction System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-04-25
• Device Publish Date: 2020-08-10

On-Brand Devices [andorate® Disposable Endoscope Valves Set]

• 04897106950492: GAR081
• 04897106950355: GAR081