TRUVIC Generator

GUDID 04719876940094

TRUVIC Tubeset, PAT10261B

TAIWAN BIOMATERIAL COMPANY LIMITED

Disposable surgical irrigation/aspiration system

• Primary Device ID: 04719876940094
• NIH Device Record Key: 0ba258aa-bc4b-47a7-937c-84cb597c7e35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUVIC Generator
• Version Model Number: PAT10261B
• 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 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719876940094 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-01
• Device Publish Date: 2022-02-21

On-Brand Devices [TRUVIC Generator]

• 04719876940117: TRUVIC Generator, PTG1B
• 04719876940100: TRUVIC Canister (White Lid), PTC001B
• 04719876940094: TRUVIC Tubeset, PAT10261B
• 04719876940124: TRUVIC Canister (Blue lid), PTC002B