Catalog Number

CS-15312-VFI

Brand Name

ARROW

Version/Model Number

IPN920784

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

K141051,K141051,K141051

Product Code

MSD

Product Code Name

Catheter, hemodialysis, implanted

Public Device Record Key

7c192c8c-726f-45bb-8b23-0e97b8402d72

Public Version Date

January 06, 2022

Public Version Number

2

DI Record Publish Date

December 23, 2021

Package DI Number

20801902197775

Quantity per Package

1

Contains DI Package

10801902197778

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box