FDA.reportPublic FDA data

Intellisense Adult Defibrillation Pads,CPR Device, Powerheart® G5

Primary DI
00812394020966
Brand
Intellisense Adult Defibrillation Pads,CPR Device, Powerheart® G5
Company
Zoll Medical Corporation
Model
XELAED002A
Catalog number
XELAED002A
Device description
Intellisense Adult defibrillation Pads, non-polarized, with CPR Feedback Device for Powerheart® G5
Published
2017-02-14
Public version status
Update
Distribution status
Not 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
LIXAid, Cardiopulmonary Resuscitation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIXAid, Cardiopulmonary ResuscitationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812394020522PreviousGS10
00812394020966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812394020522008123940205228123940205220812394020522
00812394020966008123940209668123940209660812394020966

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillator electrode, adult, single-useAn electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator to a post-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with self-affixing pads (the electrodes) prefabricated with contact gel and an adhesive, that are applied to the chest (the intact torso) of the patient so that the discharge passes across the region of the heart. This device may remain applied to the patient during stages of treatment. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1.262.953.3500techsupport@cardiacscience.com

Regulatory Flags#

DUNS number
055363428
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODE8900-004040-012026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODE8900-004041-012026-05-29
00847946021986HWD Electrode Set9610-000181-012016-10-20
10847946021327Cuffs9355-16402016-09-16
10847946021334Cuffs9355-16412016-09-16
10847946021341Cuffs9355-16422016-09-16
10847946021358Cuffs9355-16432016-09-16
10847946021365Cuffs9355-16442016-09-16
00847946023058ACCUVENT9500-0006632022-11-01
10847946023130PATIENT CIRCUITS812-0008-202022-06-08
10847946023123PATIENT CIRCUITS812-0007-202015-10-28
10847946023147PATIENT CIRCUITS812-0009-202015-10-28
10847946023154PATIENT CIRCUITS812-0010-202015-10-28
10847946023161PATIENT CIRCUITS812-0011-202015-10-28
10847946023215PATIENT CIRCUITS712-0002-202020-10-22
00847946026929RESQPOD ITD 1012-0242-0002020-06-24
20847946023137PATIENT CIRCUITS812-0008-402015-10-28
20847946023182PATIENT CIRCUITS812-0007-402015-10-28
00847946016746ZOLL CABLE1009-0918-012014-09-24
00847946016760ZOLL CABLE1009-0913-022014-09-23

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07613365002737Tempus LS-MANUALSchiller AGLIX2020-08-11
00847946020545AGILE TESTZoll Medical CorporationLIX2020-01-19
00847946020613Agile TEstZoll Medical CorporationLIX2019-01-28
00847946026332PROPAQ MDZoll Medical CorporationLIX2018-12-19
00847946021696ECGZoll Medical CorporationLIX2017-11-08
00847946023294ECGZoll Medical CorporationLIX2017-11-08
00847946023614X SERIESZoll Medical CorporationLIX2017-10-12
00847946020224PROPAQ MDZoll Medical CorporationLIX2017-09-06
00812394020973Intellisense Adult Defibrillation Pads,CPR Device, Powerheart® G5Zoll Medical CorporationLIX2017-02-10
10607415002055Moore MedicalMOORE MEDICAL LLCLIX2016-12-09
10607415002062Moore MedicalMOORE MEDICAL LLCLIX2016-12-09
07045432073355CPRmeter 2 (Multi-bundle)Laerdal Medical ASLIX2016-11-28
00847946021429ECGZoll Medical CorporationLIX2016-09-16
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00847946021481ECGZoll Medical CorporationLIX2016-09-16
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00847946021528CableZoll Medical CorporationLIX2016-09-16
00847946021733ECGZoll Medical CorporationLIX2016-09-16
00847946021764ECGZoll Medical CorporationLIX2016-09-16
00847946021771ECGZoll Medical CorporationLIX2016-09-16
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00847946021795ECGZoll Medical CorporationLIX2016-09-16
00847946021801ECGZoll Medical CorporationLIX2016-09-16
00847946021856CableZoll Medical CorporationLIX2016-09-16
00847946021665ECGZoll Medical CorporationLIX2016-09-12
00847946020033PROPAQ MDZoll Medical CorporationLIX2016-08-15
00847946021221ONESTEPZoll Medical CorporationLIX2016-08-03
00847946023348ONESTEPZoll Medical CorporationLIX2015-10-29