SinuStar

GUDID 00744229100065

SinuStar Reusable Nebulizer

PARI RESPIRATORY EQUIPMENT, INC.

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

• Primary Device ID: 00744229100065
• NIH Device Record Key: bf2a9b5e-7644-499a-bb6e-935fc411bac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SinuStar
• Version Model Number: 022F59
• 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: true
• Serial Number: false
• 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	00744229100065 [Package]; Contains: 00744229221326; Package: carton [12 Units]; In Commercial Distribution
GS1	00744229221326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061381

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: 2016-10-05

On-Brand Devices [SinuStar]

• 00744229850335: SinuStar System
• 00744229100065: SinuStar Reusable Nebulizer