Duns Number:009251992
Device Description: ELECTASSY-AED INFANTCHILD REDUCED ENERGY-WW
Catalog Number
11101-000016
Brand Name
Replacement Infant/Child AED Reduced Energy Electrodes
Version/Model Number
11101
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
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
4ba8a5be-4492-410e-b30b-a3e804a14deb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 10, 2014
Package DI Number
20721902629017
Quantity per Package
25
Contains DI Package
00721902629013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 588 |