Duns Number:038000253
Device Description: 1.9F X 20CM SINGLE TAPERLESS VASCU-PICC® FULL NUSING KIT W/MAX BARRIER
Catalog Number
MRVSP19001
Brand Name
VASCU-PICC®
Version/Model Number
MRVSP19001
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"
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
17b49c78-ea7d-4931-b2e1-77204cd91b1f
Public Version Date
September 20, 2021
Public Version Number
1
DI Record Publish Date
September 10, 2021
Package DI Number
50884908163365
Quantity per Package
3
Contains DI Package
00884908163360
Package Discontinue Date
-
Package Status
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 |