Duns Number:006261481
Device Description: SPLITTER KIT 5019 M-4 HV GLBL 17-L CE MK
Catalog Number
-
Brand Name
NA
Version/Model Number
5019
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
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
P920015
Product Code
LWS
Product Code Name
Implantable cardioverter defibrillator (non-CRT)
Public Device Record Key
337a736f-79bc-41ce-8ecc-7c3f67642110
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
June 10, 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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |