FDA.report

Kendall

Primary DI
20884521621487
Brand
Kendall
Company
Cardinal Health, Inc.
Model
33114G
Catalog number
33114G
Device description
DL Disposable Lead System
Published
2018-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
IKDCABLE, ELECTRODE

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884521621487PackageGS110In Commercial Distribution
30884521621484PackageGS1100In Commercial Distribution
10884521621480PrimaryGS10

GMDN Terms

TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00No;

Sterilization Methods

Method

Contacts

PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags

DUNS number
080935429
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 DIBrandModelCatalogPublished
20884521014937Monoject888151111088815111102016-09-24
20884521014944Monoject888151113688815111362016-09-24
20884521025674Dover888473259888847325982016-09-24
20884527021434Kendall33503335032016-09-24
20884527021441Kendall33504335042016-09-24
20884527021458Kendall33505335052016-09-24
20884527021465Kendall33506335062016-09-24
20884527021472Kendall33507335072016-09-24
20884527021489Kendall33508335082016-09-24
20884527021502Kendall33510335102016-09-24
30884521012442Monoject888120231488812023142018-06-27
20884521012469Monoject888120232288812023222018-06-27
30884521012473Monoject888120233088812023302018-06-27
30884521012497Monoject888120234888812023482018-06-27
30884521012534Monoject888120237188812023712018-06-30
30884521012558Monoject888120238988812023892018-06-27
20884521012568Monoject888120239788812023972018-06-30
20884521142760Monoject10884521142763108845211427632018-06-29
00029369211032MCDAVIDMH794002112023-05-26
90884521162088Uni-PatchMH73912MH739122018-06-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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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
06941691905431Orantech Orantech Inc.IKD2026-01-16
06941691982906Orantech Orantech Inc.IKD2026-01-16
06941691982913Orantech Orantech Inc.IKD2026-01-16
06941691982920Orantech Orantech Inc.IKD2026-01-16