Provent Sleep Therapy

Basic Information

• Brand Name: Provent Sleep Therapy
• Primary DI: 00868020000215
• Version / Model: CAT1114
• Catalog Number: CAT1114
• Company Name: PROVENT SLEEP THERAPY, LLC
• Labeler DUNS: 080469780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-25
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 594a75db-e428-4416-a58e-8e350c20f18a

Device Description

Provent 30 Night Starter Kit contains two (2) Light resistance (Phase 1) non-therapeutic acclimation units, two (2) Medium resistance (Phase 2) non-therapeutic acclimation units, and 26 Standard resistance Provent devices

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OHP	Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea	Dental	872.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11260	Nasal dilator	A surgical instrument intended to dilate nasal structures/passages during ear/nose/throat (ENT) procedures. It typically consists of a slender and cylindrical body, hollow or solid, made of metal or plastic and available in a variety of sizes and flexibilities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00868020000215	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K102404	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Expiratory Resistance 0.5 >= x <1.5 cm H2O at 50 mL/sec flow rate per nostril
Device Size Text, specify			Expiratory Resistance 1.5 >= x <3.0 cm H2O at 50 mL/sec flow rate per nostril
Device Size Text, specify			Expiratory Resistance 3.0 >= x <8.0 cm H2O at 50 mL/sec flow rate per nostril

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 40 Percent (%) Relative Humidity