LC

GUDID 00744229100560

Mouthpiece, LC Neb, Standard

PARI RESPIRATORY EQUIPMENT, INC.

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

• Primary Device ID: 00744229100560
• NIH Device Record Key: 4f8fcd11-9c78-4d9d-8f40-480bbd44fc17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LC
• Version Model Number: 012F1720P12
• 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	00744229100560 [Package]; Contains: 00744229120117; Package: carton [12 Units]; In Commercial Distribution
GS1	00744229120117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935540

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 [LC]

• 00744229100355: Nose Clip
• 00744229100331: Filter Pad
• 00744229100560: Mouthpiece, LC Neb, Standard