FDA.report

Kendall

Primary DI
20192253063124
Brand
Kendall
Company
Cardinal Health 200, LLC
Model
33136RV36
Catalog number
33136RV36
Device description
Kendall DL ECG Dual Connect Radiolucent Lead Wires, 5-Lead, Single Patient Use
Published
2023-07-14
Public version status
New
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
20192253063124PackageGS110In Commercial Distribution
50192253063125PackageGS110In Commercial Distribution
10192253063127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225306312420192253063124
5019225306312550192253063125
1019225306312710192253063127

GMDN Terms

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

TypeValueUnit
Length3Feet

Sterilization Methods

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

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10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
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B631TCGE2GE63M1SureleadAuthentic MedicalIKD2026-03-13
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