Vios Pro

GUDID 00744229312505

Vios Pro, LC Sprint, custom label

PARI RESPIRATORY EQUIPMENT, INC.

Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable

• Primary Device ID: 00744229312505
• NIH Device Record Key: 5a895693-1681-4d60-af6c-f5e8a63f7613
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vios Pro
• Version Model Number: 312F35-CAN
• Company DUNS: 804736098
• Company Name: PARI RESPIRATORY EQUIPMENT, INC.
• 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: false
• 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	00744229312017 [Primary]
GS1	00744229312505 [Package]; Contains: 00744229312017; Package: carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002862

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-30

On-Brand Devices [Vios Pro]

• 00744229100362: Tubing, replacement, Vios Pro
• 00744229312529: Vios Pro, LC Sprint, custom label
• 00744229312536: Vios Pro with LC Plus
• 00744229312512: Vios Pro with LC Sprint
• 00744229312505: Vios Pro, LC Sprint, custom label