Sinus

GUDID 00744229100300

LC Sprint Sinus Nebulizer

PARI RESPIRATORY EQUIPMENT, INC.

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

• Primary Device ID: 00744229100300
• NIH Device Record Key: 144e566d-caea-43ba-a8b4-e1625851662b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sinus
• Version Model Number: 028F2861
• 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	00744229100300 [Package]; Contains: 00744229280118; Package: carton [12 Units]; In Commercial Distribution
GS1	00744229280118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092560

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 [Sinus]

• 00744229100300: LC Sprint Sinus Nebulizer
• 00744229100287: Nose Plug, Silicone, Sinus
• 00744229100270: Filter and Screw, Sinus