Catalog Number

12005-000-0003

Brand Name

AP409-01 - PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK

Version/Model Number

12005-000-0003

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

23ed56cf-6c58-49a4-8c7d-b1f5e5a93662

Public Version Date

June 25, 2019

Public Version Number

1

DI Record Publish Date

June 17, 2019

Package DI Number

27290109159212

Quantity per Package

30

Contains DI Package

17290109159215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box