FDA.reportPublic FDA data

Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes

Primary DI
10868866000032
Brand
Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes
Company
HEART SYNC INC
Model
Sterile-C100
Catalog number
Sterile-C100
Device description
The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with "Anderson" adapted models of monophasic and bi-phasic defibrillators.
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
OTC
false
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
10868866000032PackageGS110Not in Commercial Distribution
00868866000035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086886600003210868866000032
00868866000035008688660000358688660000350868866000035

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
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.828.4681CustomerService@heartsync.net

Regulatory Flags#

DUNS number
041356039
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

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
00868866000011Heart Sync Sterile Adult Radio Transparent Multi Function ElectrodesSterile-C100-PhysioSterile-C100-Physio2014-09-16

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