Catalog Number

-

Brand Name

MiniMed® 530G

Version/Model Number

MMT-551PNAP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

P120010,P120010

Product Code

OZO

Product Code Name

Artificial pancreas device system, threshold suspend

Public Device Record Key

4d3f5cba-f712-4e6d-b52d-d1e2007906c3

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

June 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-