Catalog Number

12003-000-0024

Brand Name

AP424-01 - MICROBORE WITH NON-VENTED SPIKE, FEMALE LUER LOCK WITH A BACK CHECK V

Version/Model Number

12003-000-0024

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

K141389,K141389

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

3a37b154-00b1-447d-a19e-0d0a73aaf6ff

Public Version Date

June 25, 2019

Public Version Number

1

DI Record Publish Date

June 17, 2019

Package DI Number

27290109159243

Quantity per Package

30

Contains DI Package

17290109159246

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box