Duns Number:079105071
Device Description: 14.5F x 28cm Chronic Hemodialysis Pre-Curve Catheter Set (with Cuff 23cm from Tip)
Catalog Number
-
Brand Name
EvenMore
Version/Model Number
10303508
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"
-
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
K040402
Product Code
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
fbbb335b-ec67-4362-b302-6cbe16dfdbbc
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
September 15, 2015
Package DI Number
H787103035085
Quantity per Package
1
Contains DI Package
H787103035080
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 203 |