Duns Number:097736867
Device Description: VETA Peritoneal Catheter Kit, Curled
Catalog Number
M7225
Brand Name
VETA Peritoneal Dialysis Catheter
Version/Model Number
M7225
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
K113354,K113354,K113354
Product Code
FJS
Product Code Name
Catheter, Peritoneal, Long-Term Indwelling
Public Device Record Key
153d1622-0f09-4d13-aa38-54a4c7a059c1
Public Version Date
September 05, 2019
Public Version Number
4
DI Record Publish Date
October 15, 2015
Package DI Number
20813623015702
Quantity per Package
20
Contains DI Package
10813623015705
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 109 |