FDA.reportPublic FDA data

Electrodes (600 per case)

Primary DI
00817980020917
Brand
Electrodes (600 per case)
Company
VASOMEDICAL, INC.
Model
Model Lumenair
Catalog number
V93-0020
Device description
Electrodes (600 per case)
Published
2016-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRNDevice, counter-pulsating, external

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRNDevice, Counter-Pulsating, ExternalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033617000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033617000EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRYVasomedical, Inc.2004-03-01DRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817980020917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817980020917008179800209178179800209170817980020917

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature027 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(516)508-5818eohara@vasomedical.com

Regulatory Flags#

DUNS number
197210248
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008179800205592GB SD Memory CardModel 1303A10-00112016-11-29
008179800205663-Ch ECG Holter Patient Cable w/5 LeadsModel 1303A10-00522016-11-29
008179800205733-Ch ECG Holter Patient Cable w/7 LeadsModel 1303A10-00532016-11-29
0081798002058012-Ch ECG Holter Patient Cable w/10 LeadsModel 1304A10-00542016-11-29
00817980020597USB SD Card ReaderModel 1303A10-00152016-11-29
00817980020603Infared Communication AdaptorModel 1805A10-00222016-11-29
00817980020610Portable Case w/Belt for 1303 RecorderModel 1303A10-00412016-11-29
00817980020627Portable case with Belt for 1304/1305 RecorderModel 1304A10-00422016-11-29
00817980020634Portable case with Belt for 1805 MonitorModel 1303A10-00502016-11-29
00817980020641Portable case with Belt for 2301/2302 RecordersModel 2301A10-00432016-11-29
008179800208703 Lead Integrated ECG Cable (AngioNew® V & VI)Model AngioNew VIA12-00332016-11-29
008179800208873 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™)Model LumenairV10-00172016-11-29
008179800208943 Lead Integrated ECG Cable with adapter (Model TS3)Model TS3V10-00212016-11-29
00817980020900ECG Cable Adaptor-for use with V10-0017 (Model TS3)Model TS3V83-00662016-11-29
00817980021198Finger Plethysmograph (Models TS3 and TS4)Model TS-4V83-00062016-11-29
00817980021204Finger Plethysmograph (Model MC2, AngioNew® V& VI)Model AngioNew VIV23-00072016-11-29
00817980021402Vasomedical™ EZ™ O2 A Adult Pulse OximeterModel EZA13-0002-03-012016-11-29
00817980021419Vasomedical™ EZ™ O2 P Adult/Pediatric Pulse OximeterModel EZA13-0002-05-012016-11-29
00817980021426Vasomedical™ EZ™ Pediatric Probe for EZ™ O2 P (children over 3 yrs & Sm.Adults)Model EZA13-00702016-11-29
00817980021433Vasomedical™ EZ™ O2 Wrist Pulse OximeterModel EZA13-0002-02-012016-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979448890020HuawenVamed Medical Instrument Co.,LtdDRN2026-04-17
06971379470067PSK, Air-bag Type Sequential External Counter-pulsation DeviceChongqing PSK-Health Sci-Tech Development Co.,Ltd.DRN2025-04-15
06971379470074PSK, Air-bag Type Sequential External Counter-pulsation DeviceChongqing PSK-Health Sci-Tech Development Co.,Ltd.DRN2025-04-15
06975435800058OmayOmay(Guangzhou) Med Technologies Co.,LtdDRN2023-12-21
00865089000316RenewTM NCP-5 External Counterpulsation System S2 Equipment LLCDRN2018-06-25
06971379470012ECP PSKChongqing PSK-Health Sci-Tech Development Co.,Ltd.DRN2017-12-04
06971379470029ECP PSKChongqing PSK-Health Sci-Tech Development Co.,Ltd.DRN2017-12-04
00868331000409RejuvaHeartNORTH AMERICAN ECP INC.DRN2017-10-17
08883000001640RenewTM NCP-5 External Counterpulsation System RENEW GROUP PRIVATE LIMITEDDRN2017-03-15
00817980020740Vasomedical™ AngioNew -V EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020757Vasomedical™ AngioNew -V EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020764Vasomedical™ AngioNew -VI EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020771Vasomedical™ AngioNew -VI EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020788Vasomedical™Lumenair™ EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020795Vasomedical™Lumenair™ EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020801Vasomedical™ TS-4 EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020818Vasomedical™ TS-4EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020825Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™)VASOMEDICAL, INC.DRN2016-11-29
00817980020832Roll ECG Paper, 240 ft. (Model MC2)VASOMEDICAL, INC.DRN2016-11-29
00817980020849Nu Prep Gel, 4 oz (3 PK)VASOMEDICAL, INC.DRN2016-11-29
00817980020856Signa Electrode Gel, 8 ozVASOMEDICAL, INC.DRN2016-11-29
00817980020863Signa Electrode Gel, 2 ozVASOMEDICAL, INC.DRN2016-11-29
008179800208703 Lead Integrated ECG Cable (AngioNew® V & VI)VASOMEDICAL, INC.DRN2016-11-29
008179800208873 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™)VASOMEDICAL, INC.DRN2016-11-29
008179800208943 Lead Integrated ECG Cable with adapter (Model TS3)VASOMEDICAL, INC.DRN2016-11-29
00817980020900ECG Cable Adaptor-for use with V10-0017 (Model TS3)VASOMEDICAL, INC.DRN2016-11-29
00817980020924Cuff Set, X-SmallVASOMEDICAL, INC.DRN2016-11-29
00817980020931Cuff Set, SmallVASOMEDICAL, INC.DRN2016-11-29
00817980020948Cuff Set, MediumVASOMEDICAL, INC.DRN2016-11-29
00817980020955Cuff Set, LargeVASOMEDICAL, INC.DRN2016-11-29