| Primary Device ID | 00833224000316 |
| NIH Device Record Key | ddd21d19-9267-4fbe-a496-68dde9e4fe6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Utopia AV |
| Version Model Number | UTO253 |
| Catalog Number | UTO253 |
| Company DUNS | 103307950 |
| Company Name | Innomed Technologies Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | 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 | 800-200-9842 |
| customerservice@innomedinc.com |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00833224000316 [Primary] |
| GS1 | 50833224000311 [Package] Package: [30 Units] In Commercial Distribution |
| HIBCC | M694UTO2531 [Secondary] |
| BZD | Ventilator, Non-Continuous (Respirator) |
| 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 | 2016-09-15 |
| 00833224001047 | Utopia AV Full Face Mask - LG (with Black Headgear) |
| 00833224001030 | Utopia AV Full Face Mask - MD (with Black Headgear) |
| 00833224001023 | Utopia AV Full Face Mask - SM (with Black Headgear) |
| 00833224000323 | Utopia AV Full Face Mask - LG |
| 00833224000316 | Utopia AV Full Face Mask - MD |
| 00833224000309 | Utopia AV Full Face Mask - SM |