Catalog Number

5103190

Brand Name

VACCESS LT LONG-TERM HEMODIALYSIS CATHETER

Version/Model Number

5103190

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

-

Product Code

MSD

Product Code Name

Catheter, hemodialysis, implanted

Public Device Record Key

82649938-82fc-470a-9079-60519805e5c3

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2015

Package DI Number

10801741010658

Quantity per Package

5

Contains DI Package

00801741010651

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA