| Primary Device ID | 00814747021316 |
| NIH Device Record Key | 603005b4-b5bd-45db-bf9c-5b8913ce1171 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Extra Large Adult |
| Version Model Number | 22780 |
| Company DUNS | 785635186 |
| Company Name | SLEEPNET, CORP. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-742-3646 |
| xxx@xx.xx | |
| Phone | 1-800-742-3646 |
| xxx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814747021309 [Primary] |
| GS1 | 00814747021316 [Package] Contains: 00814747021309 Package: Case [8 Units] In Commercial Distribution |
| CBK | Ventilator, Continuous, Facility Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-05-23 |
| 00814747021316 | Disposable full face non vented mask with anti-asphyxiation valve for use in positive pressure v |
| 00814747024508 | Disposable full face non vented mask with anti-asphyxiation valve for use in positive pressure v |