DEVICE: Accessories for Endo PAT 2000 (07290109225203)
Device Identifier (DI) Information
Accessories for Endo PAT 2000
Accessories for Endo PAT 2000
In Commercial Distribution
AC0001600
ITAMAR MEDICAL LTD
Accessories for Endo PAT 2000
In Commercial Distribution
AC0001600
ITAMAR MEDICAL LTD
Accessories, EndoPAT2000
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? |
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47687 | Cardiovascular-risk peripheral arterial tonometry system |
An electrically-powered assembly of devices designed to assess peripheral artery endothelial dysfunction (poor vasodilatory response) and/or arterial stiffness through the noninvasive measurement of arterial pulsatile volume changes in the fingertip during a reactive hyperemia test (occlusion of blood flow followed by abrupt release). It typically includes a dedicated bio-sensor applied to a finger or arm and a computer/software-controlled device used to process, store, display, and help analyse peripheral arterial tone (PAT) data received from the sensor. Endothelial dysfunction is a recognized marker of sub-clinical arteriosclerosis which is used as a predictor of cardiovascular events.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQK | Computer, Diagnostic, Programmable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K032519 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 0 and 40 Degrees Celsius |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between 22 and 24 Degrees Celsius |
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e08dbaec-912a-44b2-9bfb-74a2ec164c02
June 07, 2019
4
September 06, 2016
June 07, 2019
4
September 06, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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