Adult/Child, radiolucent, leads out, defib electrodes w/ Physio connector T100LOAC-PHYSIO

GUDID 10854664006123

The Heart Sync Adult/Child Radiotranslucent 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/child 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). Comparable with Physio-Control connector models of monophasic and bi-phasic defibrillators.

HEART SYNC INC

External defibrillator electrode pad
Primary Device ID10854664006123
NIH Device Record Keye390c62f-bae5-40a5-b68b-4a8df0e21f94
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult/Child, radiolucent, leads out, defib electrodes w/ Physio connector
Version Model NumberT100LOAC-PHYSIO
Catalog NumberT100LOAC-PHYSIO
Company DUNS041356039
Company NameHEART SYNC INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net
Phone800.828.4681
EmailCustomerService@heartsync.net

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100854664006126 [Primary]
GS110854664006123 [Package]
Contains: 00854664006126
Package: [10 Units]
In Commercial Distribution

FDA Product Code

MLNElectrode, Electrodcardiograph, Multi-Function

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-31

Devices Manufactured by HEART SYNC INC

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10854664006024 - Adult/Child, radiotransparent, leads out, defib electrodes w/ Zoll connector2018-03-29 The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation
00854664006034 - Pediatric (infant), radiolucent, defib electrodes w/ Physio connector2018-03-29 The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillat
10854664006048 - Pediatric (infant), radiolucent, defib electrodes w/ Anderson connector2018-03-29 The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillat
10854664006055 - Pediatric (infant), radiolucent, defib electrodes w/ Philips connector2018-03-29 The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillat
10854664006062 - Pediatric (infant), radiolucent, defib electrodes w/ Zoll connector2018-03-29 The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillat
10854664006079 - Adult/Child, radiolucent, defib electrodes w/ Anderson connector2018-03-29 The Heart Sync Adult/Child Radiotranslucent Multi-Function Electrodes are indicated for use in external pacing, defibrillation
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