FDA.report

Kendall

Primary DI
50192253017364
Brand
Kendall
Company
Cardinal Health 200, LLC
Model
31424768
Catalog number
31424768
Device description
KittyCat 1050NPSM Neonatal, Snap, Monitoring Cloth electrode ( 3/PK)
Published
2024-02-28
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
DRXElectrode, electrocardiograph

Product Code Classifications

CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253017364PackageGS1100In Commercial Distribution
20192253017363PrimaryGS10
10192253017366Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225301736450192253017364
2019225301736320192253017363
1019225301736610192253017366

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
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
false
Sterilization required before use
false

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