DEVICE: 12 uPAT Probes for Watch-PAT (07290109222103)
Device Identifier (DI) Information
12 uPAT Probes for Watch-PAT
12 uPAT Probes for Watch-PAT
In Commercial Distribution
AC2101300
ITAMAR MEDICAL LTD
12 uPAT Probes for Watch-PAT
In Commercial Distribution
AC2101300
ITAMAR MEDICAL LTD
12 uPAT Probes
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
47686 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MNR | Ventilatory Effort Recorder |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K133859 | 000 |
K153070 | 000 |
K161579 | 000 |
K180775 | 000 |
K203839 | 000 |
K222331 | 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 0 and 93 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 68.947 and 103.42 KiloPascal |
Handling Environment Temperature: between 0 and 40 Degrees Celsius |
Handling Environment Humidity: between 10 and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 68.947 and 103.42 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
33b1c97b-b6dc-49bd-8698-4c36745ee5af
June 14, 2023
3
June 18, 2019
June 14, 2023
3
June 18, 2019
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 |
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
infousa@zoll.com
infousa@zoll.com