| Primary Device ID | 00814747022795 |
| NIH Device Record Key | 1cd5df33-d24a-4764-a5e6-3b24f45d274c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IQ 2 Nasal Vented Mask |
| Version Model Number | 50169 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814747022795 [Primary] |
| BZD | Ventilator, Non-Continuous (Respirator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-09 |
| Device Publish Date | 2022-06-01 |
| 00814747022795 | Nasal vented mask for use in positive pressure ventilation. |
| 00814747023891 | Nasal vented mask for use in positive pressure ventilation. |
| 00814747024126 | Nasal vented mask for use in positive pressure ventilation. |