Duns Number:009251992
Device Description: ELECT ASSY-EDGE,QUIK-COMBO REDI-PAK,WW
Catalog Number
11996-000017
Brand Name
EDGE Electrodes with REDI-PAK™ Preconnect System
Version/Model Number
11996
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 02, 2020
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
1dd95b69-a216-41d9-a139-2faf552f5000
Public Version Date
November 03, 2020
Public Version Number
3
DI Record Publish Date
November 10, 2014
Package DI Number
40681490580654
Quantity per Package
50
Contains DI Package
20681490580650
Package Discontinue Date
November 02, 2020
Package Status
Not 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 |