Duns Number:120818216
Device Description: 3 FR LIFECATH S MIDLINE SINGLE
Catalog Number
2296.301
Brand Name
LIFECATH S
Version/Model Number
2296.301
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062425,K062425
Product Code
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
e49e5a31-0c8f-4287-9a7c-fa403bc63898
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
October 08, 2015
Package DI Number
38498840008530
Quantity per Package
10
Contains DI Package
08498840008539
Package Discontinue Date
-
Package Status
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 | 124 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 833 |