ZOOM Aspiration Pump

GUDID 04719876940018

ZOOM Aspiration Pump, TAP1B

TAIWAN BIOMATERIAL COMPANY LIMITED

Surgical irrigation/aspiration system

• Primary Device ID: 04719876940018
• NIH Device Record Key: 7eef37d3-0fce-40ea-8365-e944840ac185
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOOM Aspiration Pump
• Version Model Number: TAP1B
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719876940018 [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: 2019-03-25
• Device Publish Date: 2019-03-15

On-Brand Devices [ZOOM Aspiration Pump]

• 04719876940025: ZOOM Canister, TC001B
• 04719876940018: ZOOM Aspiration Pump, TAP1B
• 04719876940001: ZOOM Aspiration Tubing, TAT102B
• 04719876940087: ZOOM POD Aspiration Tubing, AFT117B