Duns Number:002111896
Device Description: 1 PER PACK 10 PERCASE
Catalog Number
D315
Brand Name
Vermed DEFIB PADS
Version/Model Number
D315
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 12, 2019
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
2b95291d-5a87-4691-9fbe-4bd039152382
Public Version Date
December 13, 2019
Public Version Number
3
DI Record Publish Date
January 13, 2017
Package DI Number
20813150020194
Quantity per Package
10
Contains DI Package
10813150020197
Package Discontinue Date
December 12, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 269 |
| 3 | A medical device with high risk that requires premarket approval | 1 |