Primary Device ID | 00817613020932 |
NIH Device Record Key | 0ebf1c40-7a86-41ba-8d04-c88d6e261521 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | W1500E |
Version Model Number | W1500E |
Company DUNS | 051244569 |
Company Name | MED X CHANGE, INC. |
Device Count | 1 |
DM Exempt | true |
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 Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between 16 Degrees Celsius and 26 Degrees Celsius |
Handling Environment Humidity | Between 85 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 105 KiloPascal |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 94 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817613020932 [Primary] |
LMB | Device, Digital Image Storage, Radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-07-16 |
Device Publish Date | 2019-07-08 |
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