Proneb Ultra

GUDID 00744229850342

Replacement Filter Set, Ultra

PARI RESPIRATORY EQUIPMENT, INC.

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

• Primary Device ID: 00744229850342
• NIH Device Record Key: 508b9735-4bdc-4050-837d-4988928a147d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proneb Ultra
• Version Model Number: 085F0012P2
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00744229850328 [Primary]
GS1	00744229850342 [Package]; Contains: 00744229850328; Package: carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002862

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: 2016-11-17

On-Brand Devices [Proneb Ultra]

• 00744229850342: Replacement Filter Set, Ultra
• 00744229850359: Filter Set, Ultra
• 00744229100379: Replacement Filter
• 00744229100393: Replacement Filter, WG bulk
• 00744229100386: Replacement Filter, WG
• 00744229100317: Filter, Air