Kendall

Primary DI
30884527015607
Brand
Kendall
Company
Cardinal Health, Inc.
Model
20661
Catalog number
20661
Device description
20661 Adult Multi-Function Defibrillation Electrodes,Radiotransparent
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DROPACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012218000LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LP2001-10-12DRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884527015607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088452701560730884527015607

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30884527016048Devon31145942311459422018-06-29
10884521170728Kendall507250722016-09-24
10884527023240Kerlix258525852018-06-23
10884527023295Kerlix507250722018-06-30
10884521744585Kendall8608U8608U2017-09-07
10884521744608Kendall8617U8617U2017-09-07
10884521744622Kendall8618U8618U2017-09-07
20884521100432SharpSafety8608U8608U2016-09-24
20884521100463Monoject8617U8617U2016-09-24
20884521100470Monoject8618U8618U2016-09-24
40884521023100Monoject31142222311422222016-09-24
10884521020511Monoject888124713788812471372018-06-30
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24
20884527000088Argyle888472450488847245042018-06-30
00884521144227Webcol16818168182018-06-22
10884521189652Monoject1186000444T1186000444T2016-09-24
10884527007110Argyle888816305588881630552016-09-24
20885380173537Curity7267G7267G2019-11-14
20885380173568Curity9024G9024G2019-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10811331010319Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010326Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010333Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010340Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010357Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010364Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010371Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010388Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010395Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010401Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010418Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010425Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010432Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010449Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010456Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010463Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010647Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010654Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010661Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010678Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010685Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
10811331010692Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331010565Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331010596Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331010619Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331011098Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331011111Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331011135Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30
00811331011425Defibrillation ElectrodesTz Medical, Inc.DRO2020-12-30