| Primary Device ID | 10854664006062 |
| NIH Device Record Key | 4da6f022-2f46-4fc7-ba10-c6af84c88b7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pediatric (infant), radiolucent, defib electrodes w/ Zoll connector |
| Version Model Number | PEDIATRIC-ZOLL |
| Catalog Number | PEDIATRIC-ZOLL |
| Company DUNS | 041356039 |
| Company Name | HEART SYNC INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net | |
| Phone | 800.828.4681 |
| CustomerService@heartsync.net |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854664006065 [Primary] |
| GS1 | 10854664006062 [Package] Contains: 00854664006065 Package: [10 Units] In Commercial Distribution |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-31 |
| 10854664006000 - Adult/Child, radiolucent, defib electrodes w/ Physio connector | 2018-03-29 The Heart Sync Adult/Child Radiotranslucent Multi-Function Electrodes are indicated for use in external pacing, defibrillation |
| 10854664006017 - Adult/Child, radiotransparent, leads out, defib electrodes w/ Physio connector | 2018-03-29 The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation |
| 10854664006024 - Adult/Child, radiotransparent, leads out, defib electrodes w/ Zoll connector | 2018-03-29 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 connector | 2018-03-29 The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillat |
| 10854664006048 - Pediatric (infant), radiolucent, defib electrodes w/ Anderson connector | 2018-03-29 The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillat |
| 10854664006055 - Pediatric (infant), radiolucent, defib electrodes w/ Philips connector | 2018-03-29 The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillat |
| 10854664006062 - Pediatric (infant), radiolucent, defib electrodes w/ Zoll connector | 2018-03-29The 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. |
| 10854664006062 - Pediatric (infant), radiolucent, defib electrodes w/ Zoll connector | 2018-03-29 The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillat |
| 10854664006079 - Adult/Child, radiolucent, defib electrodes w/ Anderson connector | 2018-03-29 The Heart Sync Adult/Child Radiotranslucent Multi-Function Electrodes are indicated for use in external pacing, defibrillation |