Catalog Number

-

Brand Name

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

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

K192860,K192860

Product Code

PFA

Product Code Name

Non-Invasive Central Venous Manometer

Public Device Record Key

7d891346-95b0-42f7-a3a5-3e804bfa6e11

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 15, 2022

Package DI Number

27290109153067

Quantity per Package

30

Contains DI Package

17290109153060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboardbox