Duns Number:002348191
Device Description: Two-Lumen Hemodialysis Catheter with Blue FlexTip(R) for High Volume Infusions
Catalog Number
MC-15122-F
Brand Name
ARROW
Version/Model Number
IPN033194
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
K991431,K991431
Product Code
MPB
Product Code Name
Catheter, hemodialysis, non-implanted
Public Device Record Key
6e78c77f-0365-4bcd-a152-16806b2560f8
Public Version Date
September 21, 2021
Public Version Number
3
DI Record Publish Date
March 26, 2020
Package DI Number
10801902096767
Quantity per Package
5
Contains DI Package
20801902096764
Package Discontinue Date
September 20, 2021
Package Status
Not 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 |