Proneb Max na

GUDID 00744229100706

Proneb Max, 5 Yr, LC Sprint

PARI RESPIRATORY EQUIPMENT, INC.

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