Duns Number:315994731
Device Description: Lifecath PICC PUR
Catalog Number
1294.14
Brand Name
Lifecath PICC PUR
Version/Model Number
1294.14
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
-
Product Code
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
775b0e75-7353-4efe-82b3-1247a9854563
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
November 05, 2015
Package DI Number
53660812012275
Quantity per Package
10
Contains DI Package
03660812012270
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 13 |