Primary Device ID | 07290109222097 |
NIH Device Record Key | b8822acd-c9c5-4075-8a2a-82556680bee7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Central Plus Sensor for Watch-PAT200U |
Version Model Number | Central Plus Sensor for Watch-PAT200U |
Catalog Number | UC3000105 |
Company DUNS | 531857076 |
Company Name | ITAMAR MEDICAL LTD |
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 |
Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |