DEVICE: Watch-PAT200U (07290109222646)
Device Identifier (DI) Information
Watch-PAT200U
Watch-PAT200U
In Commercial Distribution
US2150500
ITAMAR MEDICAL LTD
Watch-PAT200U
In Commercial Distribution
US2150500
ITAMAR MEDICAL LTD
Watch-PAT200U Device
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
33843 | Polysomnograph |
A mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MNR | Ventilatory Effort Recorder |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K133859 | 000 |
K153070 | 000 |
K161579 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Atmospheric Pressure: between 68.95 and 103.42 KiloPascal |
Handling Environment Humidity: between 10 and 93 Percent (%) Relative Humidity |
Handling Environment Temperature: between 0 and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 68.95 and 103.42 KiloPascal |
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
efda391d-4b76-4088-81c9-762a55c5ac37
July 06, 2018
3
August 09, 2017
July 06, 2018
3
August 09, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
07290109222530 | 1 | 07290109222646 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+97246177000
info@itamar-medical.com
info@itamar-medical.com