Duns Number:002348191
Device Description: NextStep(R) Retograde Hemodialysis Catheter Long-Term Access. Catheter length, Cuff to Tip NextStep(R) Retograde Hemodialysis Catheter Long-Term Access. Catheter length, Cuff to Tip: 31 cm
Catalog Number
CS-15312-X
Brand Name
ARROW
Version/Model Number
IPN033050
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K111117,K111117,K111117
Product Code
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
0159d32a-69d6-4310-a695-2a9e209d81d2
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
October 16, 2015
Package DI Number
30801902096402
Quantity per Package
1
Contains DI Package
10801902096408
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |