Vios

GUDID 00744229311065

Vios Nebulizer System, LC Sprint

PARI RESPIRATORY EQUIPMENT, INC.

Nebulizing system delivery set, reusable

• Primary Device ID: 00744229311065
• NIH Device Record Key: 39e84aa8-9f4b-45f5-99c5-5570642445ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vios
• Version Model Number: 310F35-LCS
• 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	00744229310587 [Primary]
GS1	00744229311065 [Package]; Contains: 00744229310587; Package: carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092918

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: 2016-09-27

On-Brand Devices [Vios]

• 00744229311058: Vios Nebulizer System, LC Sprint, custom label
• 00744229311126: Vios Nebulizer System, LC Sprint, custom label
• 00744229311188: Vios Nebulizer System, LC Plus, custom label
• 00744229311119: Vios Nebulizer System, LC Sprint, custom label
• 00744229310846: Vios Compressor, Replacement
• 00744229311171: Vios Nebulizer System, LC Plus, Pediatric
• 00744229311164: Vios Nebulizer System, LC Plus, custom label
• 00744229311157: Vios Nebulizer System, LC Plus, custom label
• 00744229311140: Vios Nebulizer System, LC Plus
• 00744229311133: Vios Nebulizer System, LC Plus, custom label
• 00744229311102: Vios Nebulizer System, LC Sprint, custom label
• 00744229311096: Vios Nebulizer System, LC Sprint, Pediatric
• 00744229311089: Vios Nebulizer System, LC Sprint, custom label
• 00744229311072: Vios Nebulizer System, LC Sprint, custom label
• 00744229311065: Vios Nebulizer System, LC Sprint
• 00744229311041: Vios Nebulizer System, LC Sprint, custom label
• 00744229311034: Vios Nebulizer System, LC Sprint, custom label
• 00744229311027: Vios Nebulizer System, LC Sprint, custom label
• 00744229311010: Vios Nebulizer System, LC Sprint, custom label