Catalog Number

CS-15552-VFE

Brand Name

ARROW

Version/Model Number

IPN055259

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K111117,K111117,K111117

Product Code

MSD

Product Code Name

Catheter, hemodialysis, implanted

Public Device Record Key

65014cea-72e0-4e14-aa7b-f77088960eb3

Public Version Date

February 24, 2022

Public Version Number

4

DI Record Publish Date

April 24, 2019

Package DI Number

30801902156045

Quantity per Package

1

Contains DI Package

10801902156041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box