HolterCare

Primary DI
00856298006169
Brand
HolterCare
Company
SCOTTCARE CORPORATION, THE
Model
HolterCare
Catalog number
100087
Device description
The ScottCare HolterCare Analysis System is intended for general hospital or clinical use bymedical 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 memoryHolter recorder. This product allows a trained physician, or other health care professional, todownload and analyze the data from the recorder, review it, and produce printed reports. This willenable: 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 inthe 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 intendedfor any home-use applications.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042463000HOLTER PLUSRozinn Electronics, Inc.2004-09-22DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856298006169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856298006169008562980061698562980061690856298006169

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording analyser application softwareA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
216-362-0550service@scottcare.com

Regulatory Flags#

DUNS number
808204957
Device count
1
Lot or batch
true

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