Catalog Number

SHW19-75

Brand Name

Port Access Needle

Version/Model Number

SHW19-75

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

711fe98a-5483-41ad-b935-10ede942b730

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

August 05, 2016

Package DI Number

20801741089750

Quantity per Package

4

Contains DI Package

10801741089753

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX