| Primary Device ID | 53915187400272 |
| NIH Device Record Key | e5376ee0-7095-4a79-90e5-5a1311496eda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hyperbox System |
| Version Model Number | Hyperbox System, 115VAC |
| Catalog Number | G00002 |
| Company DUNS | 896654477 |
| Company Name | AOTI LIMITED |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 53915187400272 [Primary] |
| KPJ | Chamber, Oxygen, Topical, Extremity |
| 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 | 2017-07-17 |
| 53915187499900 | The Hyper-Box Homecare System is intended to be used for the treatment of acute and chronic woun |
| 53915187400272 | The Hyper-Box Topical Wound Oxygen System is intended to be used for the treatment of acute and |