Duns Number:002348191
Device Description: 15 Fr. x 19 cm NextStep(R) Antegrade Hemodialysis Catheterization Set, Long-Term Access Ca 15 Fr. x 19 cm NextStep(R) Antegrade Hemodialysis Catheterization Set, Long-Term Access Catheter Length, Tip to Cuff: 19 cm
Catalog Number
AC-15192-SFX
Brand Name
ARROW
Version/Model Number
IPN032550
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
K111900,K111900,K111900
Product Code
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
cd90f423-c16b-4085-98f9-462108af35f2
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
October 16, 2015
Package DI Number
10801902109504
Quantity per Package
1
Contains DI Package
00801902109507
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 | 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 |