andorate® Port Brush

GUDID 04897106957040

GA Health Company Limited

Surgical instrument/endoscope cleaning utensil, single-use

• Primary Device ID: 04897106957040
• NIH Device Record Key: 59dc90b4-371c-4b4a-b2d8-fdabd7fb274e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: andorate® Port Brush
• Version Model Number: SDPC0193
• Company DUNS: 686908512
• Company Name: GA Health Company Limited
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04897106957040 [Primary]
GS1	14897106957047 [Package]; Package: Box [250 Units]; In Commercial Distribution
GS1	24897106957044 [Package]; Contains: 14897106957047; Package: Carton [2 Units]; In Commercial Distribution

FDA Product Code

• MNL: Accessories, Cleaning Brushes, For Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-15
• Device Publish Date: 2024-08-07

On-Brand Devices [andorate® Port Brush]

• 14897106953612: SDPC0193
• 04897106957040: SDPC0193