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 |