FDA.report

Sustainable Technologies

Primary DI
10192253064698
Brand
Sustainable Technologies
Company
Cardinal Health 200, LLC
Model
33110B
Catalog number
33110B
Device description
Kendall DL 10 Leads System Blended Case - Single-patient-use
Published
2024-06-03
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
50192253064696PrimaryGS10
10192253064698Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225306469650192253064696
1019225306469810192253064698

GMDN Terms

TermDefinition
Electrocardiographic lead set, reprocessedA collection of noninvasive devices intended 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 is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a previously used single-use device that has been processed for an additional single-use patient application.

Device Sizes

TypeValueUnit
Length10Feet

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
50
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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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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20653405017759CONMEDConmed CorporationIKD2026-03-24
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B631DLSRPHP5L4F1SureLeadAuthentic MedicalIKD2026-03-13
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B631TCGE2GE63M1SureleadAuthentic MedicalIKD2026-03-13
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