Catalog Number

12003-000-0013

Brand Name

AP403-01 - MICROBORE WITH VENTED/NON-VENTED SPIKE

Version/Model Number

12003-000-0013

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"

-

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

K192860,K192860

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

1cd9d4ac-96c2-4a26-bd04-aebe6963db9f

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 15, 2022

Package DI Number

27290109153043

Quantity per Package

30

Contains DI Package

17290109153046

Package Discontinue Date

November 14, 2021

Package Status

Not in Commercial Distribution

Package Type

Cardboardbox