FDA.reportPublic FDA data

Cuff Set, Large

Primary DI
00817980020955
Brand
Cuff Set, Large
Company
VASOMEDICAL, INC.
Model
Model Lumenair
Catalog number
V23-0002
Device description
Cuff Set, Large
Published
2016-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00817980020955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817980020955008179800209558179800209550817980020955

GMDN Terms#

Term, Definition table
TermDefinition
External counterpulsation system, stationaryA noninvasive, stationary assembly of devices intended to assist the blood circulation of an adult patient suffering from heart disease through the electrocardiogram (ECG) synchronized inflation of pressure cuffs worn around the extremities/buttocks. It includes a patient bed with inflatable cuffs, an air pump, ECG cables, and either a control unit or software for use with a personal computer (PC); it may include a pulse oximeter probe. The cuffs are intended to inflate from the most distal to the most proximal during diastole and deflate during systole to increase preload/decrease afterload. The system is intended to be operated by a professional in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
197210248
Device count
1

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
00817980020917Electrodes (600 per case)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