FDA.report

Medi-Trace Cadence

Primary DI
50192253018873
Brand
Medi-Trace Cadence
Company
Cardinal Health 200, LLC
Model
22661R
Catalog number
22661R
Device description
Medi-Trace Cadence Adult, Defibrillation electrode -RTS (10 PR/PK) - Philips barrell
Published
2021-07-29
Public version status
New
Distribution status
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
50192253018873PackageGS110In Commercial Distribution
20192253018872PrimaryGS10
10192253018875Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225301887350192253018873
2019225301887220192253018872
1019225301887510192253018875

GMDN Terms

TermDefinition
External defibrillator electrode padA conductive medium designed to be used between the metal contact surface of an external defibrillator electrode, of the paddle-type, and the patient's skin. A defibrillator electrode pad is available in two basic designs: 1) a thickened conductive gel or polymer layer reinforced by a non-woven material; or 2) a conductive adhesive pad with a metal contact on its outer surface. This is a single-use device.

Sterilization Methods

Method

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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