DEVICE: Watch-PAT 200i (07290109222974)
Device Identifier (DI) Information
Watch-PAT 200i
Watch-PAT 200i
In Commercial Distribution
AS2150306
ITAMAR MEDICAL LTD
Watch-PAT 200i
In Commercial Distribution
AS2150306
ITAMAR MEDICAL LTD
Watch-PAT200 Device
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MNR | Ventilatory Effort Recorder |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K081037 | 000 |
Sterilization
Storage and Handling
[?]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 |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
7017bfe2-400f-4461-ab55-297cc8c40898
July 06, 2018
3
November 20, 2016
July 06, 2018
3
November 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
07290109222943 | 1 | 07290109222974 | 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