Catalog Number

328611

Brand Name

Medtronic MiniMed Pro-Set Infusion Set, Luer Connection 42in

Version/Model Number

328611

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K160651,K160651,K160651

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

56d4e9c6-18d8-46a3-baa8-0cad0f2acabf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 03, 2016

Package DI Number

50382903286114

Quantity per Package

15

Contains DI Package

00382903286119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case