DEVICE: 12 Pneumatic Endo probes for Endo PAT 2000 (07290109225005)

Device Identifier (DI) Information

12 Pneumatic Endo probes for Endo PAT 2000
12 Pneumatic Endo probes for Endo PAT 2000
In Commercial Distribution
AC1600005
ITAMAR MEDICAL LTD
07290109225005
GS1

1
531857076 *Terms of Use
12 Pneumatic Endo 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
DQK Computer, Diagnostic, Programmable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K032519 000
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Sterilization

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

[?]
Storage and Handling
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Temperature: between 22 and 24 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

e2630e40-d13d-4c1e-9445-f4a1562a7944
July 06, 2018
3
September 05, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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

[?]
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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