FDA.report

Intellisense Adult Defibrillation Pads, CPR Device, Powerheart® G5

Primary DI
00812394020522
Brand
Intellisense Adult Defibrillation Pads, CPR Device, Powerheart® G5
Company
Cardiac Science Corporation
Model
XELAED002A
Catalog number
XELAED002A
Device description
Intellisense Adult defibrillation Pads, non-polarized, with CPR Feedback Device for Powerheart® G5
Published
2015-12-21
Public version status
Update
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

Contact Domains

Product Codes

CodeName
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications

CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812394020522PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
00812394020522140081239402052208123940205220812394020522Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

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

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

Contacts

PhoneEmail
+1.262.953.3500techsupport@cardiacscience.com

Regulatory Flags

DUNS number
190713797
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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00847946046118Sunmed721-0013-002021-10-22
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00847946046132Sunmed712-0015-002021-10-22
00847946046156Sunmed912-0009-202021-10-22
00847946046163Sunmed912-0010-202021-10-22
00847946046170Sunmed912-0011-202021-10-22
00847946046187Powerheart® G5 ElectrodesXELAED001C2021-08-18
00847946046194Powerheart® G5 ElectrodesXELAED002C2021-08-18
00847946046200Powerheart® G5 ElectrodesXELAED003C2021-08-18
00812394023301Powerheart® AED G3 Plus Automatic AED9390A-1001-TSO9390A-1001-TSO2020-12-02
00812394023172Powerheart® AED G3 Automatic AED9300A-019300A-012020-12-01
00812394023189Powerheart® AED G3 Automatic AED9300A-1001-TSO9300A-1001-TSO2020-12-01
00812394023202Powerheart® AED G3 Semi-Automatic AED9300E-019300E-012020-12-01
00812394023219Powerheart® AED G3 Semi Automatic AED9300E-1001-TSO9300E-1001-TSO2020-12-01
00812394023233Powerheart® AED G3 Pro9300P-019300P-012020-12-01
00812394023240Powerheart® AED G3 Pro AED9300P-10019300P-10012020-12-01
00812394023257Powerheart® AED G3 Pro AED, Stocking Package9300P-1001SP9300P-1001SP2020-12-01
00812394023271Powerheart® AED G3 Plus Automatic AED9390A-019390A-012020-12-01
00812394023288Powerheart® AED G3 Plus Automatic AED9390A-10019390A-10012020-12-01
00812394023295Powerheart® AED G3 Plus Automatic AED, stocking package9390A-1001SP9390A-1001SP2020-12-01

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