eRapid

GUDID 00744229178088

eRapid Nebulizer System

PARI RESPIRATORY EQUIPMENT, INC.

Ultrasonic nebulizing system

• Primary Device ID: 00744229178088
• NIH Device Record Key: b6311f40-5bcb-495e-b86e-b8831aecf0fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eRapid
• Version Model Number: 178G1030
• 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: 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	00744229178057 [Primary]
GS1	00744229178088 [Package]; Contains: 00744229178057; Package: carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112859

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: 2016-09-26

On-Brand Devices [eRapid]

• 00744229789062: SmartMask Baby
• 00744229789055: Replacement Battery Door, Gray
• 00744229789000: Smartmask Kids
• 00744229780052: Adapter, AC, multi-voltage
• 00744229678175: eBase Controller, eRapid
• 00744229178071: eRapid Nebulizer Handset
• 00744229178088: eRapid Nebulizer System