FDA.reportPublic FDA data

Provent Sleep Therapy

Primary DI
00868020000215
Brand
Provent Sleep Therapy
Company
PROVENT SLEEP THERAPY, LLC
Model
CAT1114
Catalog number
CAT1114
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
Published
2017-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHPExpiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHPExpiratory Resistance Valve, Intranasal, For Obstructive Sleep ApneaDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102404000PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)Ventus Medical, Inc.2010-12-02OHP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868020000215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868020000215008680200002158680200002150868020000215

GMDN Terms#

Term, Definition table
TermDefinition
Nasal dilatorA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity40 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-757-9355info@proventtherapy.com

Regulatory Flags#

DUNS number
080469780
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868020000208Provent Sleep TherapyCAT1105CAT11052017-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10833224005011Bongo RxAirAvant MedicalOHP2024-10-21
10833224005110Bongo RxAirAvant MedicalOHP2024-10-21
50833224005019Bongo RxAirAvant MedicalOHP2024-10-21
50833224005118Bongo RxAirAvant MedicalOHP2024-10-21
10833224005004Bongo RxAirAvant MedicalOHP2019-04-10
10833224005028Bongo RxAirAvant MedicalOHP2019-04-10
10833224005035Bongo RxAirAvant MedicalOHP2019-04-10
10833224005042Bongo RxAirAvant MedicalOHP2019-04-10
10833224005059Bongo RxAirAvant MedicalOHP2019-04-10
10833224005127Bongo RxAirAvant MedicalOHP2019-04-10
10833224005134Bongo RxAirAvant MedicalOHP2019-04-10
10833224005141Bongo RxAirAvant MedicalOHP2019-04-10
10833224005158Bongo RxAirAvant MedicalOHP2019-04-10
50833224005002Bongo RxAirAvant MedicalOHP2019-04-10
50833224005026Bongo RxAirAvant MedicalOHP2019-04-10
50833224005033Bongo RxAirAvant MedicalOHP2019-04-10
50833224005040Bongo RxAirAvant MedicalOHP2019-04-10
50833224005057Bongo RxAirAvant MedicalOHP2019-04-10
50833224005125Bongo RxAirAvant MedicalOHP2019-04-10
50833224005132Bongo RxAirAvant MedicalOHP2019-04-10
50833224005149Bongo RxAirAvant MedicalOHP2019-04-10
50833224005156Bongo RxAirAvant MedicalOHP2019-04-10
00868020000208Provent Sleep TherapyPROVENT SLEEP THERAPY, LLCOHP2017-08-25