Provent Sleep Therapy CAT1105

GUDID 00868020000208

Provent 30 Night Standard Pack contains 30 Standard resistance Provent

PROVENT SLEEP THERAPY, LLC

Nasal dilator

• Primary Device ID: 00868020000208
• NIH Device Record Key: 1174e15c-8b26-47db-b8e8-465bb831697a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provent Sleep Therapy
• Version Model Number: CAT1105
• Catalog Number: CAT1105
• Company DUNS: 080469780
• Company Name: PROVENT SLEEP THERAPY, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-757-9355
• Email: info@proventtherapy.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868020000208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102404

FDA Product Code

• OHP: Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

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: 2017-08-25

On-Brand Devices [Provent Sleep Therapy]

• 00868020000215: Provent 30 Night Starter Kit contains two (2) Light resistance (Phase 1) non-therapeutic acclima
• 00868020000208: Provent 30 Night Standard Pack contains 30 Standard resistance Provent