Duns Number:015510540
Device Description: 3.5Fr x 60cm Dual Lumen PICC, MST
Catalog Number
3525-2660
Brand Name
NeoMagic
Version/Model Number
3539-2660
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
K953300,K953300
Product Code
LJS
Product Code Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Public Device Record Key
2b17cdd6-a8ca-44dd-98f5-31ad56af1812
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
B339352526605
Quantity per Package
10
Contains DI Package
B339352526600
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |