FDA.reportPublic FDA data

Sage 12c

Primary DI
00815871021425
Brand
Sage 12c
Company
Avante
Model
60130H
Published
2016-09-23
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
MWJElectrocardiograph,Ambulatory(Without Analysis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151787000Holter SystemEdan Instruments, Inc.2016-01-27DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815871021425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815871021425008158710214258158710214250815871021425

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic ambulatory recorderAn 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
502-244-4444devicehelp@dremed.com

Regulatory Flags#

DUNS number
178440426
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815871021647VISION LEDDRE 0615122016-09-23
00815871021685VISION LEDDRE 061512-V2016-09-23
00815871021722VISION EX5DRE 0614122016-09-23
00815871021807Vista LEDDRE 0613122016-09-23
00815871021845Vista LEDDRE 061312-V2016-09-23
00815871022163VISION LEDDRE 0615222017-01-31
00815871022200VISION LEDDRE 061522-V2017-02-01
00815871022248VISION EX5DRE 0614222017-02-01
00815871022286VISION EX5DRE 061422-V2017-02-01
00815871022323Vista LEDDRE 0613222017-02-01
00815871022361Vista LEDDRE 061322-V2017-02-01
00815871020008ASG 12071250ASG2016-09-23
00815871020015ASG 12071250ASGR2016-09-23
00815871020022ASG 2007200ASG2016-09-23
00815871020039ASG 2007200ASGR2016-09-23
00815871020046ASG 3007300ASG2016-09-23
00815871020053ASG 3007300ASGR2016-09-23
00815871021432EG-30070300MB2016-09-23
00815871021449EG-Pro70S4002016-09-23
00815871020107Nasal CO2 Sampling Cannula With O2 DeliveryP03082D2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278840202MACGe Medical Systems Information Technologies, Inc.DQK2026-10-13
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00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQK2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQK2026-10-04
06975817741030DMS 300-2 Holter RecorderDm Systems (Beijing) Co., Ltd.MWJ2026-09-30
05415067057952EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
05415067057969EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-09-20
00885403523512HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403523536HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403533764Smart Pressure ControllerBecton, Dickinson And CompanyDQK2026-09-18
00885403533771Smart Pressure Controller Accessory KitBecton, Dickinson And CompanyDQK2026-09-18
00199150062911N/AMEDTRONIC, INC.DQK2026-09-04
00198953213063ComboLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213087CardioLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213094Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055668EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055675EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055682EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
00885403523437HemoSphere AltaBecton, Dickinson And CompanyDQK2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyDQK2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyDQK2026-08-06
00885403532040FloTracBecton, Dickinson And CompanyDQK2026-07-31
06975817741016DMS 300-3A Holter RecorderDm Systems (Beijing) Co., Ltd.MWJ2026-07-22
06975817741023DMS 300-4AL Holter RecorderDm Systems (Beijing) Co., Ltd.MWJ2026-07-22
06975817741047DMS 300-4A Holter RecorderDm Systems (Beijing) Co., Ltd.MWJ2026-07-22
06975817741054DMS 300-2W Holter RecorderDm Systems (Beijing) Co., Ltd.MWJ2026-07-22