DEVICE: HolterCare (00856298006169)

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Device Identifier (DI) Information

HolterCare
HolterCare
100087
SCOTTCARE CORPORATION, THE
00856298006169
GS1
1
The ScottCare HolterCare Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient’s long-term, continuous, ambulatory electrocardiogram (ECG). The long-term ECG is recorded on a digital flash memory Holter recorder. This product allows a trained physician, or other health care professional, to download and analyze the data from the recorder, review it, and produce printed reports. This will enable:  The evaluation of arrhythmias and ischemic attacks.  The reporting of PQRST intervals.  Clinical and epidemiological research studies.  The evaluation of a patient’s response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery).  The evaluation of patients with Pacemakers. The need to record, review, edit, and archive the ambulatory ECG is most commonly encountered in the Cardiology areas of the hospital, or physician’s office, during cardiac assessment of a patient. This device is available for sale to, or on the order of, a licensed physician only and is not intended for any home-use applications.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

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 recording analyser application software A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
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FDA Product Code

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Product Code Product Code Name
DQK Computer, Diagnostic, Programmable
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Sterilization

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

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Storage and Handling
No storage/handling found
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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
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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216-362-0550
service@scottcare.com
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