HolterCare 100087

GUDID 00856298006169

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.

SCOTTCARE CORPORATION, THE

Electrocardiographic long-term ambulatory recording analyser application software
Primary Device ID00856298006169
NIH Device Record Key579ccc3e-ebc6-46cc-86ae-223337185128
Commercial Distribution StatusIn Commercial Distribution
Brand NameHolterCare
Version Model NumberHolterCare
Catalog Number100087
Company DUNS808204957
Company NameSCOTTCARE CORPORATION, THE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone216-362-0550
Emailservice@scottcare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856298006169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

Devices Manufactured by SCOTTCARE CORPORATION, THE

00856298006428 - EZLink-R2024-05-31
00856298006435 - EZLink-C2024-05-31
00856298006008 - Chroma2019-11-08 The Chroma model RZ153C Holter monitor is a battery operated solid-state recorder. It is designed for up to 48 hours (2 days) co
00856298006015 - Chroma22019-11-08
00856298006022 - TeleSenseRCM2019-11-08 The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events
00856298006039 - TeleSense-E2019-11-08 The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events
00856298006220 - Chroma 5 Lead Patient Cable2019-11-08 5 lead ECG patient cable to be used with the Chroma device.
00856298006312 - Chroma 7 Lead Patient Cable2019-11-08 7 lead ECG patient cable to be used with the Chroma device.

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