Catalog Number

-

Brand Name

t:slim X2 Insulin Pump with Basal-IQ

Version/Model Number

1005698

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

P180008,P180008,P180008,P180008

Product Code

OZO

Product Code Name

Automated Insulin Dosing , Threshold Suspend

Public Device Record Key

9910c195-776f-4492-a1a1-6fd26d07a4bb

Public Version Date

February 12, 2020

Public Version Number

1

DI Record Publish Date

February 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-