FDA.reportPublic FDA data

Kendall ECG Leads

Primary DI
00816317024291
Brand
Kendall ECG Leads
Company
RENU MEDICAL, INC
Model
RM-33114N
Device description
Cardinal Health Kendall Philips INTEL TELE LEAD SET WITH SHOWER SHIELD 5 Lead 5 Pin 50in
Published
2025-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816317024298PackageGS110In Commercial Distribution
00816317024291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081631702429810816317024298
00816317024291008163170242918163170242910816317024291

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
100439103
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816317024499HoverMatt Lateral Transfer MatRM-PROS-HM2026-09-21
00816317024420Kendall DVT SleeveRM-830222026-01-27
00816317024437Kendall DVT SleeveRM-830232026-01-27
00816317024444Kendall DVT SleeveRM-830242026-01-27
10816317024427Kendall DVT SleeveRM-830222026-01-27
10816317024434Kendall DVT SleeveRM-830232026-01-27
10816317024441Kendall DVT SleeveRM-830242026-01-27
00816317024413HoverMatt Lateral Transfer MatRM-HM34SPU-SPLIT-B2025-10-30
00816317023997Nellcor Pulse Oximeter ProbeRM-MAX-P2025-07-08
10816317023994Nellcor Pulse Oximeter ProbeRM-MAX-P2025-07-08
00816317024307Kendall ECG LeadsRM-33136R362025-05-01
00816317024321Kendall ECG LeadsRM-33136RT722025-05-01
00816317024338Kendall ECG LeadsRM-33136RT362025-05-01
00816317024345Kendall ECG LeadsRM-33137T2025-05-01
00816317024352Kendall ECG LeadsRM-331132025-05-01
00816317024369Kendall ECG LeadsRM-33154T2025-05-01
10816317024304Kendall ECG LeadsRM-33136R362025-05-01
00816317024314Kendall ECG LeadsRM-33136R722025-05-01
10816317024328Kendall ECG LeadsRM-33136RT722025-05-01
10816317024335Kendall ECG LeadsRM-33136RT362025-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936735495924UnimedUnimed Medical Supplies, Inc.IKD2026-11-04
06936735496044UnimedUnimed Medical Supplies, Inc.IKD2026-11-04
06936735496051UnimedUnimed Medical Supplies, Inc.IKD2026-11-04
06936735496075UnimedUnimed Medical Supplies, Inc.IKD2026-11-04
06936735496082UnimedUnimed Medical Supplies, Inc.IKD2026-11-04
06936735496778UnimedUnimed Medical Supplies, Inc.IKD2026-11-04
06936735496785UnimedUnimed Medical Supplies, Inc.IKD2026-11-04
06936735497201UnimedUnimed Medical Supplies, Inc.IKD2026-11-04
04719872982555QT ECGQt Medical, Inc.IKD2026-10-28
50885380213234KendallCardinal Health 200, LLCIKD2026-10-28
50885380213241KendallCardinal Health 200, LLCIKD2026-10-28
50885380213258KendallCardinal Health 200, LLCIKD2026-10-28
06946725572931APKAPK Technology Co.,Ltd.IKD2026-10-26
06946725502341APKAPK Technology Co.,Ltd.IKD2026-10-22
06946725500989APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500996APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501009APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501016APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501030APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501047APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501054APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501061APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501078APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501085APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501092APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501108APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501115APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501122APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501139APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501146APKAPK Technology Co.,Ltd.IKD2025-07-22