DEVICE: 12 Pneumo-opt Slp Probes for Watch-PAT 200S-3 (07290109222004)

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Device Identifier (DI) Information

12 Pneumo-opt Slp Probes for Watch-PAT 200S-3
12 Pneumo-opt Slp Probes for Watch-PAT 200S-3
AC2100210
ITAMAR MEDICAL LTD
07290109222004
GS1
1
12 Pneumo-opt Slp Probes
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Cardiovascular-risk peripheral arterial tonometry system sensor An pneumo-electronic device, typically designed as a proximal annular cuff incorporating plethysmography-based pneumatic bio-sensor, that is placed on a patient's finger during a reactive hyperemia test for the assessment of endothelial dysfunction (poor vasodilatory response) and arterial stiffness. It is connected to the cardiovascular-risk peripheral arterial tonometry system data processor and imparts a uniform pressure field to the distal two thirds of the finger, including the tip, to measure arterial pulsatile volume changes. This is a single-use device.
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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
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 68.947 and 103.42 KiloPascal
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Atmospheric Pressure: between 68.947 and 103.42 KiloPascal
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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
September 06, 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
07290109222028 1 07290109222004 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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

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