Provent Sleep Therapy CAT1105

GUDID 00868020000208

Provent 30 Night Standard Pack contains 30 Standard resistance Provent

PROVENT SLEEP THERAPY, LLC

Nasal dilator
Primary Device ID00868020000208
NIH Device Record Key1174e15c-8b26-47db-b8e8-465bb831697a
Commercial Distribution StatusIn Commercial Distribution
Brand NameProvent Sleep Therapy
Version Model NumberCAT1105
Catalog NumberCAT1105
Company DUNS080469780
Company NamePROVENT SLEEP THERAPY, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-757-9355
Emailinfo@proventtherapy.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100868020000208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OHPExpiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-25

On-Brand Devices [Provent Sleep Therapy]

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

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