PEP-S

GUDID 00744229100003

PEP-S Positive Expiratory Pressure System

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: 00744229100003
• NIH Device Record Key: 3f90d82a-3af2-4f0e-9316-31c4ddf4691e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEP-S
• Version Model Number: 018F63
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00744229100003 [Package]; Contains: 00744229180128; Package: carton [12 Units]; In Commercial Distribution
GS1	00744229180128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090829

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: 2016-09-30

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