Primary Device ID | 07290109222523 |
NIH Device Record Key | 67552ba8-1f30-4f38-a024-5c0799a36bbe |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Watch-PAT200U |
Version Model Number | Watch-PAT200U |
Catalog Number | AS2150500 |
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 |
Phone | +97246177000 |
info@itamar-medical.com |
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 |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 68.95 KiloPascal and 103.42 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07290109222523 [Package] Contains: 07290109222639 Package: [1 Units] In Commercial Distribution |
GS1 | 07290109222639 [Primary] |
MNR | Ventilatory Effort Recorder |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-08-09 |
07290109222899 | Watch-PAT200U Device (EU) |
07290109222844 | Watch-PAT200U Device (EU) |
07290109222738 | Watch-PAT200U Device |
07290109222691 | Watch-PAT200U Device |
07290109222646 | Watch-PAT200U Device |
07290109222523 | Watch-PAT200U Device |