Duns Number:302846407
Device Description: Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
Catalog Number
90404
Brand Name
S&W
Version/Model Number
DF28N
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
8ce90a38-ddd2-418a-ac79-0d71c48293cb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2014
Package DI Number
30869956000059
Quantity per Package
6
Contains DI Package
20869956000052
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. | 9 |
| 3 | A medical device with high risk that requires premarket approval | 17 |