SinuStar

GUDID 00744229850335

SinuStar System

PARI RESPIRATORY EQUIPMENT, INC.

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

• Primary Device ID: 00744229850335
• NIH Device Record Key: 8c2c22ff-ffb3-4ae4-a3fc-7e1a90dbee40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SinuStar
• Version Model Number: 085F77-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	00744229850311 [Primary]
GS1	00744229850335 [Package]; Contains: 00744229850311; Package: carton [6 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-17

On-Brand Devices [SinuStar]

• 00744229850335: SinuStar System
• 00744229100065: SinuStar Reusable Nebulizer