Catalog Number

M7100

Brand Name

VETA Peritoneal Dialysis Catheter

Version/Model Number

M7100

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

K113354,K113354,K113354

Product Code

FJS

Product Code Name

Catheter, Peritoneal, Long-Term Indwelling

Public Device Record Key

378bc0b8-5eaa-496c-b107-873475892725

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 15, 2015

Package DI Number

10813623016078

Quantity per Package

5

Contains DI Package

00813623016071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-