TRI-FLO™ TF28010

GUDID 50190752144475

Subglotic Suction System

VYAIRE MEDICAL, INC.

Airway suction catheter

• Primary Device ID: 50190752144475
• NIH Device Record Key: 43950b87-4474-4799-b0ca-c60467943a73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRI-FLO™
• Version Model Number: TF28010
• Catalog Number: TF28010
• Company DUNS: 080456871
• Company Name: VYAIRE MEDICAL, INC.
• 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: true
• 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

Customer Support Contacts

• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752144477 [Primary]
GS1	50190752144475 [Package]; Contains: 10190752144477; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• BSY: CATHETERS, SUCTION, TRACHEOBRONCHIAL

Sterilization

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

[50190752144475]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-20
• Device Publish Date: 2019-12-20

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