DEVICE: CPRmeter 2 (Multi-bundle) (07045432073355)
Device Identifier (DI) Information
CPRmeter 2 (Multi-bundle)
801
In Commercial Distribution
801-00249
Laerdal Medical AS
801
In Commercial Distribution
801-00249
Laerdal Medical AS
The CPRmeter 2 CPR feedback device is a portable, battery-powered device intended to provide real-time feedback on manual chest compression (i.e depth of compression) performed during cardiopulmonary resuscitation (CPR) on a patient in cardiac arrest, or during training on a resuscitation training model. It typically consists of a chest plate with a digital display, which is placed on the sternum and pushed down during chest compression and will display compression depth and rate, measured by one of various electronic technologies (e.g., electromagnetic signaling to a baseplate, accelerometer). It is intended to be used by those trained in CPR.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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60368 | Cardiopulmonary resuscitation feedback device, electronic |
A portable, battery-powered device intended to provide real-time feedback on manual chest compressions (i.e., depth of compression) performed during cardiopulmonary resuscitation (CPR) on a patient in cardiac arrest, or during training on a resuscitation training model. It typically consists of a chest plate with a digital display, which is placed on the sternum and pushed down during chest compressions and will display compression depth and rate, measured by one of various electronic technologies (e.g., electromagnetic signaling to a baseplate, accelerometer). It is intended to be used by those trained in CPR.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LIX | Aid, Cardiopulmonary Resuscitation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 0 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c4b8564d-101c-4087-8aa6-ac6c0bd71fad
January 03, 2019
5
November 28, 2016
January 03, 2019
5
November 28, 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
[?]
(877) 523-7325
customerservice@laerdal.com (800) 431-1055
customerservice@laerdal.com
customerservice@laerdal.com (800) 431-1055
customerservice@laerdal.com