FDA.reportPublic FDA data

Kendall

Primary DI
20192253063179
Brand
Kendall
Company
Cardinal Health 200, LLC
Model
33150
Catalog number
33150
Device description
Kendall DL ECG Direct Connect Telemetry Lead Wires for Philips MX40 Monitors, 6-Lead, Single Patient Use, Nellcor SpO2
Published
2023-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
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
20192253063179PackageGS110In Commercial Distribution
50192253063170PackageGS110In Commercial Distribution
10192253063172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225306317920192253063179
5019225306317050192253063170
1019225306317210192253063172

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead switching adaptorA switching device to which electrocardiograph (ECG) limb and chest leads may be attached. It is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations (e.g., leads I, II and III). This device will typically be used when the devices to be connected are from different manufacturer's, enabling them to mate together. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Feet

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20192253019992KendallCardinal Health 200, LLCIKD2026-05-26
06946725550748APKAPK Technology Co.,Ltd.IKD2026-05-22
06946725555316APKAPK Technology Co.,Ltd.IKD2026-05-22
06946725571477APKAPK Technology Co.,Ltd.IKD2026-05-22
20653405017759CONMEDConmed CorporationIKD2026-03-24
20885380202480KendallCardinal Health 200, LLCIKD2026-03-20
20885380202497KendallCardinal Health 200, LLCIKD2026-03-20
B631ADX2GE61SureleadAuthentic MedicalIKD2026-03-13
B631DLSRPHP5L4F1SureLeadAuthentic MedicalIKD2026-03-13
B631EXTGE6PL8F1SureleadAuthentic MedicalIKD2026-03-13
B631TCGE2GE63M1SureleadAuthentic MedicalIKD2026-03-13
20885380208536CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
20885380208543CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
50885380208551CARDINAL HEALTHCardinal Health 200, LLCIKD2026-03-03
06946725509180APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725509319APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725509784APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725509906APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725513484APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725513491APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725513507APKAPK Technology Co.,Ltd.IKD2026-02-27
06946725513514APKAPK Technology Co.,Ltd.IKD2026-02-27
00850011306291High Density Tether 7.5mNEURALYNX, INC.IKD2026-02-19
00850011306307Tether Extension Cable Male-to-Male 3mNEURALYNX, INC.IKD2026-02-19
07613327688764N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-02-10
00849593025720AMCAdvantage Medical Electronics, LLCIKD2026-02-05
00849593025737AMCAdvantage Medical Electronics, LLCIKD2026-02-05
06941691983132Orantech Orantech Inc.IKD2026-01-29
06946725513200APKAPK Technology Co.,Ltd.IKD2026-01-23
06946725513217APKAPK Technology Co.,Ltd.IKD2026-01-23