Catalog Number

SHW19-75YS

Brand Name

Port Access Needle

Version/Model Number

SHW19-75YS

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

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

91bfc1f0-5edd-454a-858e-cdaec121f2de

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

August 05, 2016

Package DI Number

10801741089777

Quantity per Package

25

Contains DI Package

00801741089770

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA