FDA.reportPublic FDA data

Waveline VS

Primary DI
00815871022156
Brand
Waveline VS
Company
Avante
Model
60180V
Published
2017-02-10
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
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DSACable, Transducer And Electrode, Patient, (Including Connector)
DSIDetector And Alarm, Arrhythmia
DSKComputer, Blood-Pressure
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
FLLThermometer, Electronic, Clinical
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2
DSIDetector And Alarm, ArrhythmiaCardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113653000PATIENT MONITOREdan Instruments, Inc.2012-02-06MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815871022156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815871022156008158710221568158710221560815871022156

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

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
00093764604737A&D MedicalA&D COMPANY, LIMITEDDXN2026-09-25
00093764604744A&D MedicalA&D COMPANY, LIMITEDDXN2026-09-25
G662ME590015H1MaguireMaguire Enterprises, Inc.DSA2026-09-24
06953825911874AlphaMedShenzhen Urion Technology Co., LtdDXN2026-09-22
00749756389181DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
05415067057952EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
05415067057969EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-09-20
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
06953825911850sakerplusShenzhen Urion Technology Co., LtdDXN2026-09-18
00199150062911N/AMEDTRONIC, INC.DQK2026-09-04
03700506301775INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-08-27
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
06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DRT2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DRT2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26