Primary Device ID | D787213AC25B11 |
NIH Device Record Key | f58ae743-3be6-4bd0-9a6b-dcc67ae170c5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | XDR |
Version Model Number | Anatomic Sensor, Size 2 |
Catalog Number | 213AC25B1 |
Company DUNS | 112029934 |
Company Name | CYBER MEDICAL IMAGING, INC. |
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 | false |
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 |
Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |