Catalog Number

-

Brand Name

t:slim X2 5.0 Insulin Pump

Version/Model Number

1003487

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

P140015,P140015

Product Code

OYC

Product Code Name

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Public Device Record Key

0ecf9c57-c1f0-4a03-8f34-91b3d61fca93

Public Version Date

November 15, 2018

Public Version Number

1

DI Record Publish Date

October 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-