Duns Number:055363428
Device Description: Defibrillator ,MAIN, AED-3, 12 LEAD, SPO2/ETCO2, BT/GPS, PACE, AC, RAILS, DMST, REFURB
Catalog Number
-
Brand Name
E SERIES
Version/Model Number
80001310030164012
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111594
Product Code
MKJ
Product Code Name
Automated external defibrillators (non-wearable)
Public Device Record Key
07f5aa3c-566d-465b-872e-b77e7ae35364
Public Version Date
September 09, 2020
Public Version Number
4
DI Record Publish Date
October 06, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1473 |
| 3 | A medical device with high risk that requires premarket approval | 1032 |