FDA.report

Kendall

Primary DI
50192253017258
Brand
Kendall
Company
Cardinal Health 200, LLC
Model
31086575
Catalog number
31086575
Device description
KITTYCAT 4105 Metallic Pre-Wired Foam Electrode, Nonsterile, Product Code 31086575
Published
2023-06-15
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications

CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253017258PackageGS1100Not in Commercial Distribution
20192253017257PrimaryGS10
10192253017250Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225301725850192253017258
2019225301725720192253017257
1019225301725010192253017250

GMDN Terms

TermDefinition
Neonatal electrocardiographic electrodeA non-sterile electrical conductor applied to a neonatal patient to transmit electrical signals from the body surface to a data measuring/display device (typicaly an electrocardiograph, patient monitor, or patient monitoring system) to produce an electrocardiogram (ECG). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Protect from Light
Storage Environment Temperature12 Degrees Celsius32 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
3
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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

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