Catalog Number

12004-000-0002

Brand Name

AP214-01- MICROBORE YELLOW MARKED INFUSION SET WITH VENTED/NON-VENTED SPIK

Version/Model Number

12004-000-0002

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

K192860,K192860

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

362f8bf9-6ce8-47cc-89a1-47036f4cc3b2

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 15, 2022

Package DI Number

27290109153050

Quantity per Package

30

Contains DI Package

17290109154555

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboardbox