| Primary Device ID | 00868020000215 |
| NIH Device Record Key | 594a75db-e428-4416-a58e-8e350c20f18a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Provent Sleep Therapy |
| Version Model Number | CAT1114 |
| Catalog Number | CAT1114 |
| 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 |
| Phone | 888-757-9355 |
| info@proventtherapy.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868020000215 [Primary] |
| OHP | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-25 |
| 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 |