Primary Device ID | 04589607250019 |
NIH Device Record Key | cdecc741-1e1a-45e0-b864-b9887b12d761 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | YS-3GA |
Company DUNS | 690971676 |
Company Name | YOSHIDA DENZAI KOGYO CO., LTD. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 69 KiloPascal and 106 KiloPascal |