Catalog Number

S01120-10

Brand Name

Port Access Needle

Version/Model Number

S01120-10

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

38c2f293-ec77-41d4-8c57-cdeda4333fff

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

20801741048580

Quantity per Package

8

Contains DI Package

10801741048583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX