FDA.reportPublic FDA data

Velocity EKG

Primary DI
00815871020893
Brand
Velocity EKG
Company
Avante
Model
60134
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815871020893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815871020893008158710208938158710208930815871020893

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel). It may be intended for use while the patient is at rest (rest ECG) and/or during physical exercise (stress/exercise ECG), and may include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
178440426
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815871020091Disposable Monopolar Handswitching PencilP005072016-09-23
00815871020190Compact FM601302016-09-23
00815871020206Compact FM60130EXP2016-09-23
00815871020213Compact FM60130T2016-09-23
00815871020220Compact FM60130TD2016-09-23
00815871020237Compact Plus601312016-09-23
00815871020244Compact Plus60131EXP2016-09-23
00815871020251Compact Plus60131B2016-09-23
00815871020268Compact Plus60131EXP22016-09-23
00815871020275Compact Plus60131I2016-09-23
00815871020282Compact Plus60131EXPI2016-09-23
00815871020343DM-66070130P2016-09-23
00815871020350DM-66070130PE2016-09-23
00815871020909Waveline EZ+601442016-09-23
00815871020916Waveline EZ+60144CO22016-09-23
00815871020923Waveline EZ+60144CO2S2016-09-23
00815871020930Waveline EZ+60144IBP2016-09-23
00815871020947Waveline EZ+60144NP2016-09-23
00815871020954Waveline EZ+60144TIBP2016-09-23
00815871020961Waveline EZ+60144TNIBP2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809276943958Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276943965Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276943972Cardio P1Bionet CO,LTDDPS2026-05-26
08809276944269Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276944276Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
00884838117358patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-05
00884838117273patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117280patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117297patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117303patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117310patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117327patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117334patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117341patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00843997011006Radius VSMMASIMO CORPORATIONDPS2026-02-23
00843997016018Radius VSMMASIMO CORPORATIONDPS2026-02-23
00884838131958Cardiologs PlatformPHILIPS FRANCEDPS2026-02-16
00732094360363Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-02-03
00732094360370Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-02-03
G697100010010CloudHRV™ SystemInmedix, Inc.DPS2026-01-30
00198953107263MACGe Medical Systems Information Technologies, Inc.DPS2026-01-27
00884838117198patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117204patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117211patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117228patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117259patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-15
00884838117266patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-15
00884838117235patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2025-12-15
00884838117242patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2025-12-15
00732094237740Welch Allyn, Inc.WELCH ALLYN, INC.DPS2025-09-22