Catalog Number

-

Brand Name

t:slim X2 5.0 Insulin Pump

Version/Model Number

1000897

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

1d5531f3-4ae0-48f6-a324-9579a4419cdb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-