TRUVIC Generator

GUDID 04719876940094

TRUVIC Tubeset, PAT10261B

TAIWAN BIOMATERIAL COMPANY LIMITED

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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