Catalog Number

12003-000-0023

Brand Name

AP423- MICROBORE WITH NON-VENTED SPIKE AND A BACK CHECK VALVE

Version/Model Number

12003-000-0023

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

K141834,K141834

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

d6a0ff6c-2474-4a52-96b2-0ab36c248652

Public Version Date

June 25, 2019

Public Version Number

1

DI Record Publish Date

June 17, 2019

Package DI Number

27290109159236

Quantity per Package

30

Contains DI Package

17290109159239

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box