FDA.report

Medi-Trace Cadence

Primary DI
20192253017615
Brand
Medi-Trace Cadence
Company
Cardinal Health 200, LLC
Model
22661PC
Catalog number
22661PC
Device description
Medi-Trace Cadence Adult, Pre-Connect Defibrillation electrode (10 PR/PK) - Philips barrell
Published
2021-07-29
Public version status
Update
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
MKJAutomated external defibrillators (non-wearable)

Product Code Classifications

CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253017616PackageGS110Not in Commercial Distribution
20192253017615PrimaryGS10
10192253017618Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225301761650192253017616
2019225301761520192253017615
1019225301761810192253017618

GMDN Terms

TermDefinition
Electrode conductive skin pad, single-useA noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device.

Regulatory Flags

DUNS number
961027315
Device count
2
DM exempt
false
Premarket exempt
false
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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10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
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