FDA.reportPublic FDA data

HRV Acquire

Primary DI
00702173456508
Brand
HRV Acquire
Company
WR MEDICAL ELECTRONICS CO INC
Model
5650
Published
2016-07-25
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
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092809000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092809000HRV ACQUIREWr Medical Electronics Co.2010-10-19DRT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00702173456508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00702173456508007021734565087021734565080702173456508

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic monitorA mains electricity (AC-powered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart rate. The device is typically equipped with audible and/or visual alarms that are triggered when the patient's parameters drop below or exceed pre-set limits.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-604-8400info@wrmed.com

Regulatory Flags#

DUNS number
006196604
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00702173131870Surgical Probe Monopolar31872016-08-29
00702173131887Surgical Probe, Monopolar w/Protected Plug31882016-08-29
00702173132174Silverstein Facial Nerve Stimulator Remote Probe32172016-08-29
00702173139005Hilger Dual Stim39002016-08-29
00702173139050Hilger Dual-Stimulator Remote Probe39052016-08-29
00702173139104Silverstein Facial Nerve StimulatorS82016-08-29
00702173122755TherabathTB92020-03-11
00702173122809TherabathTB102019-11-06
00702173151885Q-Sweat51882016-09-12
00702173151915Meridian™ Iontophoretic Drug Delivery Electrode51912016-09-12
00702173152929Meridian™ Iontophoretic Drug Delivery Electrode52922017-06-06
00702173155920Iontophor®-II6111PM/DX2017-02-21
00702173355696CASEIV2016-08-29
00702173123202TherabathTB62016-08-29
00702173123226TherabathTB72016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDRT2026-04-15
08809988780049Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300-E)Xandar Kardian Korea Inc.DRT2025-12-04
00850005949671BioButton Charging StationBIOINTELLISENSE, INC.DRT2025-11-19
00856298006343Aermos softwareScottCare Cardiovascular SolutionsDRT2025-10-28
00856298006381Aermos Tx DeviceScottCare Cardiovascular SolutionsDRT2025-10-28
00856298006411AermosSCOTTCARE CORPORATION, THEDRT2025-10-28
00856298006442Aermos Tx Patiet CableScottCare Cardiovascular SolutionsDRT2025-10-28
00850005949466BioDashboardBIOINTELLISENSE, INC.DRT2025-02-28
00850005949596BioButton Charging StationBIOINTELLISENSE, INC.DRT2025-02-19