Andorate

GUDID 26970661242799

Disposable Endoscope Valves Set

Smartdata Suzhou Co., Ltd.

Endoscope channel support kit

• Primary Device ID: 26970661242799
• NIH Device Record Key: afb1e61d-81df-4edc-a7de-7f2505958242
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Andorate
• Version Model Number: GAR081P
• Company DUNS: 529507479
• Company Name: Smartdata Suzhou Co., Ltd.
• 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	06970661242795 [Primary]
GS1	16970661242792 [Package]; Contains: 06970661242795; Package: Outer Box [50 Units]; In Commercial Distribution
GS1	26970661242799 [Package]; Contains: 16970661242792; Package: Carton [4 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-02
• Device Publish Date: 2019-08-26

Devices Manufactured by Smartdata Suzhou Co., Ltd.

• 16970661241498 - Andorate®: 2020-05-06
• 16970661241733 - Andorate®: 2020-05-06
• 26970661242799 - Andorate: 2019-10-02Disposable Endoscope Valves Set
• 26970661242799 - Andorate: 2019-10-02 Disposable Endoscope Valves Set
• 16970661240330 - Andorate®: 2019-10-02
• 16970661241030 - Andorate®: 2019-10-02
• 16970661241542 - Andorate®: 2019-10-02