Catalog Number

12000-000-0027

Brand Name

AP431-01 INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER,BACK CHECK VALVE,

Version/Model Number

12000-000-0027

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

K123049,K123049

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

4678b555-b28a-4a1d-b158-6705da911b69

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

27290109150516

Quantity per Package

20

Contains DI Package

17290109150519

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cardboard box