FDA.reportPublic FDA data

Pediatric (infant), radiolucent, defib electrodes w/ Zoll connector

Primary DI
00854664006065
Brand
Pediatric (infant), radiolucent, defib electrodes w/ Zoll connector
Company
HEART SYNC INC
Model
PEDIATRIC-ZOLL
Catalog number
PEDIATRIC-ZOLL
Device description
The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-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 pediatric patients whose weight is less than 10 kg (100 joules). 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). Comparable with Zoll connector models of monophasic and bi-phasic defibrillators.
Published
2016-08-31
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
LDDDc-Defibrillator, Low-Energy, (Including Paddles)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDDDc-Defibrillator, Low-Energy, (Including Paddles)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854664006062PackageGS110In Commercial Distribution
00854664006065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085466400606210854664006062
00854664006065008546640060658546640060650854664006065

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
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
00868866000028Heart Sync Sterile Adult Radio Transparent Multi Function ElectrodesSterile-C100-ZollSterile-C100-Zoll2014-09-16

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