AccessGUDID - DEVICE: Provent Sleep Therapy (00868020000215)

GUDID

Device Identifier (DI) Information

Brand Name: Provent Sleep Therapy
Version or Model: CAT1114
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAT1114
Company Name: PROVENT SLEEP THERAPY, LLC

Primary DI Number: 00868020000215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080469780 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHP	Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102404	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 0 and 40 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type 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

Device Record Status

Public Device Record Key: 594a75db-e428-4416-a58e-8e350c20f18a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 25, 2017