Duns Number:038000253
Device Description: 4F X 60CM DUAL LUMEN4F X 60CM DU VASCU-PICC®FULL NURSING KITKIT
Catalog Number
MR17014206
Brand Name
VASCU-PICC®AND MIDLINE CATHETERS
Version/Model Number
MR17014206
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 06, 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
Yes
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
44d4cfe0-24ef-45a6-a4e2-263c4a7981df
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
May 14, 2019
Package DI Number
50884908140359
Quantity per Package
5
Contains DI Package
00884908140354
Package Discontinue Date
December 06, 2019
Package Status
Not in Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |