Duns Number:079105071
Device Description: 14.5F x 22cm EvenMore Straight Hemodialysis Catheter (with Cuff 17cm from Tip)
Catalog Number
-
Brand Name
EvenMore
Version/Model Number
10303612
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 27, 2021
Issuing Agency
In HIBCC
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,K040402
Product Code
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
2639ee74-5aa3-47e9-a885-54611bfc4ae9
Public Version Date
May 31, 2021
Public Version Number
5
DI Record Publish Date
September 15, 2015
Package DI Number
H787103036125
Quantity per Package
5
Contains DI Package
H787103036120
Package Discontinue Date
May 27, 2021
Package Status
Not 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 |