Proneb Max na

GUDID 00744229100706

Proneb Max, 5 Yr, LC Sprint

PARI RESPIRATORY EQUIPMENT, INC.

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

• Primary Device ID: 00744229100706
• NIH Device Record Key: f7f17033-f956-4615-a2bb-8e0ceb03cb44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proneb Max
• Version Model Number: 130F35-LCS
• Catalog Number: na
• Company DUNS: 804736098
• Company Name: PARI RESPIRATORY EQUIPMENT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00744229100706 [Package]; Contains: 00744229130017; Package: carton [6 Units]; In Commercial Distribution
GS1	00744229130017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191270

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: 2023-06-29
• Device Publish Date: 2020-05-22

On-Brand Devices [Proneb Max]

• 00744229130062: Replacement Filter, Proneb Max
• 00744229100706: Proneb Max, 5 Yr, LC Sprint