ZOOM™ Duoport Canister

GUDID 04719876940186

An accessories of Zoom Asipration Pump. Commercial prodcut name (Brand name): ZOOM™ Duoport Canister Model number: TDC001B

Taiwan Biomaterial Company Limited

Thrombectomy electric suction pump, reusable

• Primary Device ID: 04719876940186
• NIH Device Record Key: 16db3e95-ecb0-4865-b0c0-efa6580abe0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOOM™ Duoport Canister
• Version Model Number: TDC001B
• Company DUNS: 656073408
• Company Name: Taiwan Biomaterial 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Store at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719876940186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190105

FDA Product Code

• JCX: Apparatus, Suction, Ward Use, Portable, Ac-Powered

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: 2025-03-04
• Device Publish Date: 2025-02-24

Devices Manufactured by Taiwan Biomaterial Company Limited

• 04719876940186 - ZOOM™ Duoport Canister: 2025-03-04An accessories of Zoom Asipration Pump. Commercial prodcut name (Brand name): ZOOM™ Duoport Canister Model number: TDC001B
• 04719876940186 - ZOOM™ Duoport Canister: 2025-03-04 An accessories of Zoom Asipration Pump. Commercial prodcut name (Brand name): ZOOM™ Duoport Canister Model number: TDC001B
• 04719876940124 - TRUVIC Generator: 2024-02-27 TRUVIC Canister (Blue lid), PTC002B
• 04719876940094 - TRUVIC Generator: 2022-03-01 TRUVIC Tubeset, PAT10261B
• 04719876940100 - TRUVIC Generator: 2022-03-01 TRUVIC Canister (White Lid), PTC001B
• 04719876940117 - TRUVIC Generator: 2022-03-01 TRUVIC Generator, PTG1B
• 04719876940087 - ZOOM Aspiration Pump: 2021-12-27 ZOOM POD Aspiration Tubing, AFT117B
• 04719876940001 - ZOOM Aspiration Pump: 2019-05-27 ZOOM Aspiration Tubing, TAT102B
• 04719876940018 - ZOOM Aspiration Pump: 2019-03-25 ZOOM Aspiration Pump, TAP1B