Duns Number:038000253
Device Description: 5F X 20CM DUAL LUMEN5F X 20CM DU MIDLINE FULL NURSING KITMIDLINE W/MAX BARRIERW/MAX BARRIE 5F X 20CM DUAL LUMEN5F X 20CM DU MIDLINE FULL NURSING KITMIDLINE W/MAX BARRIERW/MAX BARRIER
Catalog Number
ML5D20MB
Brand Name
VASCU-PICC®AND MIDLINE CATHETERS
Version/Model Number
ML5D20MB
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
-
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
19b5c3f5-b386-49be-9cb4-d315a4ff4f15
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
May 25, 2019
Package DI Number
50884908140434
Quantity per Package
3
Contains DI Package
00884908140439
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 |