DEVICE: Chroma (00856298006008)

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Device Identifier (DI) Information

Chroma
RZ153C
101273
SCOTTCARE CORPORATION, THE
00856298006008
GS1
1
The Chroma model RZ153C Holter monitor is a battery operated solid-state recorder. It is designed for up to 48 hours (2 days) continuous recording of ambulatory electrocardiograph (AECG) data on a single AAA battery. It has the ability to detect and record pacemaker pulses according to the appropriate criteria for Association for the Advancement of Medical Instrumentation (AAMI) pacer detection.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electrocardiographic long-term ambulatory recorder An automated, battery-powered device designed to continuously record electrocardiographic signals in ambulatory patients for periods greater than 24 hours, for the diagnosis of cardiac disorders (e.g., arrhythmias). Often called a Holter monitor, it includes a data recorder, surface electrodes that are worn on the chest of the patient, and may include accessories intended for attachment/removal (e.g., wipes, adhesive remover). The recorded data is analysed at a medical/diagnostic facility using an electrocardiographic analyser (e.g., Holter analyser) or a computer, with dedicated software. The recorder may also allow for manual recording of symptoms (e.g., palpitations, shortness of breath).
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FDA Product Code

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Product Code Product Code Name
MWJ Electrocardiograph,Ambulatory(Without Analysis)
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Handling Environment Temperature: between -20 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 19, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Customer Contact

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216-362-0550
service@scottcare.com
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