DEVICE: Watch-PAT 200i (07290109222974)

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Device Identifier (DI) Information

Watch-PAT 200i
Watch-PAT 200i
AS2150306
ITAMAR MEDICAL LTD
07290109222974
GS1
1
Watch-PAT200 Device
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
MNR Ventilatory Effort Recorder
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 68.95 and 103.42 KiloPascal
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Handling 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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
November 20, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
07290109222943 1 07290109222974 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+97246177000
info@itamar-medical.com
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