Duns Number:790268031
Catalog Number
EX3000
Brand Name
SJM™
Version/Model Number
EX3000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NIK
Product Code Name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Public Device Record Key
5de2980b-11cc-4646-bef4-553992ffcb28
Public Version Date
February 04, 2019
Public Version Number
4
DI Record Publish Date
January 19, 2015
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 | 70 |
2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
3 | A medical device with high risk that requires premarket approval | 736 |