FDA.reportPublic FDA data

Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes

Primary DI
00868866000011
Brand
Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes
Company
HEART SYNC INC
Model
Sterile-C100-Physio
Catalog number
Sterile-C100-Physio
Device description
The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use inexternal pacing, defibrillation and monitoring applications as a sterile, disposable device for singlepatient use only. The electrodes provide the conductive interface between the defibrillator and/or theexternal transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode isintended for use on adult patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or externalpacing, these electrodes will be applied to the patient and connected to the instrument. This device isintended for use on defibrillators whose output is classified as low power (360 joule maximum).Compatible with Physio Control quik combo® adapted models of monophasic and bi-phasicdefibrillators.
Published
2014-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10868866000018PackageGS110Not in Commercial Distribution
00868866000011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086886600001810868866000018
00868866000011008688660000118688660000110868866000011

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
800.828.4681CustomerService@heartsync.net

Regulatory Flags#

DUNS number
041356039
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854664006003Adult/Child, radiolucent, defib electrodes w/ Physio connectorT100AC-PHYSIOT100AC-PHYSIO2016-08-30
00854664006010Adult/Child, radiotransparent, leads out, defib electrodes w/ Physio connectorC100LOAC-PHYSIOC100LOAC-PHYSIO2016-08-30
00854664006027Adult/Child, radiotransparent, leads out, defib electrodes w/ Zoll connectorC100LOAC-ZOLLC100LOAC-ZOLL2016-08-30
00854664006041Pediatric (infant), radiolucent, defib electrodes w/ Anderson connectorPED-100PED-1002016-08-31
00854664006058Pediatric (infant), radiolucent, defib electrodes w/ Philips connectorPEDIATRIC-PHILIPSPEDIATRIC-PHILIPS2016-08-31
00854664006065Pediatric (infant), radiolucent, defib electrodes w/ Zoll connectorPEDIATRIC-ZOLLPEDIATRIC-ZOLL2016-08-31
00854664006072Adult/Child, radiolucent, defib electrodes w/ Anderson connectorT100ACT100AC2016-08-30
00854664006089Adult/Child, radiolucent, defib electrodes w/ Phillips connectorT100AC-PHILIPST100AC-PHILIPS2017-03-25
00854664006096Adult/Child, radiolucent, defib electrodes w/ Zoll connectorT100AC-ZOLLT100AC-ZOLL2016-08-30
00854664006119Adult/Child, radiolucent, leads out, defib electrodes w/ Phillips connectorT100LOAC-PHILIPST100LOAC-PHILIPS2016-08-31
00854664006126Adult/Child, radiolucent, leads out, defib electrodes w/ Physio connectorT100LOAC-PHYSIOT100LOAC-PHYSIO2016-08-31
00854664006133Adult/Child, radiolucent, leads out, defib electrodes w/ Zoll connectorT100LOAC-ZOLLT100LOAC-ZOLL2016-08-31
00854664006140Adult/Child, radiotransparent, defib electrodes with large back-posterior pad w/C200AC-PHILIPSC200AC-PHILIPS2016-08-31
00854664006157Adult/Child, radiotransparent, defib electrodes with large back-posterior pad w/C200AC-PHYSIOC200AC-PHYSIO2016-08-31
00854664006164Adult/Child, radiotransparent, defib electrodes with large back-posterior pad w/C200AC-ZOLLC200AC-ZOLL2016-08-31
00854664006171Adult/Child, radiotransparent, defib electrodes with increased adhesive surface C300AC-PHILIPSC300AC-PHILIPS2016-08-31
00854664006188Adult/Child, radiotransparent, defib electrodes with increased adhesive surface C300AC-PHYSIOC300AC-PHYSIO2016-08-31
00854664006195Adult/Child, radiotransparent, defib electrodes with increased adhesive surface C300AC-ZOLLC300AC-ZOLL2016-08-31
00854664006201Adult/Child, radiolucent, defib electrodes w/ 10 foot lead wire with Zoll connecT100AC-ZOLL-10T100AC-ZOLL-102016-08-31
00868866000028Heart Sync Sterile Adult Radio Transparent Multi Function ElectrodesSterile-C100-ZollSterile-C100-Zoll2014-09-16

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