LC

GUDID 00744229100355

Nose Clip

PARI RESPIRATORY EQUIPMENT, INC.

Mechanical positive pressure airway secretion-clearing device Mechanical positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device

• Primary Device ID: 00744229100355
• NIH Device Record Key: f56e64a1-5d32-4af5-9c9c-5146372c724f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LC
• Version Model Number: 041F3500
• 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	00744229100355 [Package]; Contains: 00744229410881; Package: carton [12 Units]; In Commercial Distribution
GS1	00744229410881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972042

FDA Product Code

• BWF: Spirometer, Therapeutic (Incentive)

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