Primary Device ID | B1400510BS0 |
NIH Device Record Key | 45924e14-5527-4e55-89da-2e4d97538523 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BRAEBON Ultima Breath Sensor Interface |
Version Model Number | 0510BS |
Catalog Number | 0510BS |
Company DUNS | 251731105 |
Company Name | Braebon Medical Corporation |
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 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |