DEVICE: Chroma (00856298006008)
Device Identifier (DI) Information
Chroma
RZ153C
In Commercial Distribution
101273
SCOTTCARE CORPORATION, THE
RZ153C
In Commercial Distribution
101273
SCOTTCARE CORPORATION, THE
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.
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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35162 | Electrocardiographic ambulatory recorder |
An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).
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FDA Product Code
[?]Product Code | Product Code Name |
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MWJ | Electrocardiograph,Ambulatory(Without Analysis) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K083382 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -20 and 40 Degrees Celsius |
Handling Environment Temperature: between -20 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
66c5a265-9a58-4296-86cf-9e1408cbed2b
November 08, 2019
4
September 19, 2016
November 08, 2019
4
September 19, 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
[?]
216-362-0550
service@scottcare.com
service@scottcare.com