Duns Number:041356039
Device Description: The Heart Sync Pediatric(infant) Radiotranslucent Multifunction Electrodes are indicated f
Catalog Number
PEDIATRIC-ZOLL
Brand Name
Pediatric (infant), radiolucent, defib electrodes w/ Zoll connector
Version/Model Number
PEDIATRIC-ZOLL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LDD
Product Code Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Public Device Record Key
4da6f022-2f46-4fc7-ba10-c6af84c88b7d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 2016
Package DI Number
10854664006062
Quantity per Package
10
Contains DI Package
00854664006065
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| 3 | A medical device with high risk that requires premarket approval | 3 |