Catalog Number

-

Brand Name

PASV MS Kit

Version/Model Number

MS4K

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code

LJS

Product Code Name

Catheter,intravascular,therapeutic,long-term greater than 30 days

Public Device Record Key

2fdea8d3-2d78-4a2b-9a38-c050b4c4274a

Public Version Date

August 13, 2021

Public Version Number

4

DI Record Publish Date

September 17, 2015

Package DI Number

M001MS4K1

Quantity per Package

5

Contains DI Package

M001MS4K0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX