Catalog Number

AN652034

Brand Name

AllPoints Port Access System PowerLoc

Version/Model Number

AN652034

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

Yes

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

f66fe1fa-127f-49b8-aca2-ee38b3c3c464

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Package DI Number

10801741215442

Quantity per Package

10

Contains DI Package

00801741215445

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA