Catalog Number

-

Brand Name

MiniMed™ 770G

Version/Model Number

MMT-1880

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

P160017

Product Code

OZP

Product Code Name

Automated insulin dosing device system, single hormonal control

Public Device Record Key

699b42e2-b3cf-446c-a5d0-a2d7908f3bba

Public Version Date

October 20, 2020

Public Version Number

1

DI Record Publish Date

October 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-