Catalog Number

AP07014US

Brand Name

INTERA

Version/Model Number

AP-07014US

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

-

Product Code

LKK

Product Code Name

Pump, Infusion, Implanted, Programmable

Public Device Record Key

33ff01da-a1fa-459d-8a76-8ed5fd1594a9

Public Version Date

March 28, 2022

Public Version Number

2

DI Record Publish Date

August 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-