Duns Number:041356039
Device Description: Can be used in place of Cardiac Science™ electrodes part # 9131-001.Indicated for use to t Can be used in place of Cardiac Science™ electrodes part # 9131-001.Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse andnot breathing spontaneously. Heart Sync T100-CS AED pads are single use and intended tobe used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor anddeliver defibrillation energy to the patient. The T100-CS AED pads are used on patients over8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8hours)
Catalog Number
T100-CS
Brand Name
Heart Sync T-CardiacSci-AED™ Pads
Version/Model Number
T100-CS
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
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
8cfc6f72-c690-4c94-aadb-8088231b7bd2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2014
Package DI Number
10868866000001
Quantity per Package
10
Contains DI Package
00868866000004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |