DEVICE: GD (00862186000317)
Device Identifier (DI) Information
GD
Prep-Check 30Hz
In Commercial Distribution
EIM-105-30Hz
General Devices
Prep-Check 30Hz
In Commercial Distribution
EIM-105-30Hz
General Devices
The Prep-Check 30Hz is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes a applied to patients. Impedance readings are measured at 30 Hz.
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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35028 | Electrocardiographic electrode tester |
An instrument designed to measure the electrical impedance between the surface of external electrocardiography electrodes and the skin; it is also typically capable of measuring interference voltages that may be stored on electrodes (i.e., offset voltage) and/or detect faulty lead wires and cables. The device is mainly used to assess the ability of a set of surface (skin) electrodes to conduct bioelectric signals from the skin to the electrodes; it can also measure the impedance of the lead wires and cables from the electrodes to the measuring unit. It is intended to be used by a healthcare provider in a clinical setting.
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FDA Product Code
[?]Product Code | Product Code Name |
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KRC | Tester, Electrode, Surface, Electrocardiographic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K830876 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
f57e3fc1-1dff-450f-8439-0d1b147c0b15
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined