Duns Number:827900809
Device Description: The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitorin The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitoring brand that set the standard for accuracy and performance in sensor-augmented pumps. The t:slim G4 Pump is the only pump that conveniently combines CGM graphs and trend information with current insulin delivery together on a single color touch screen to help you make more informed decisions.
Catalog Number
-
Brand Name
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM
Version/Model Number
006194
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,P140015,P140015,P140015,P140015,P140015,P140015,P140015
Product Code
OYC
Product Code Name
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Public Device Record Key
88428bbf-16ac-418d-b123-45d0e686a814
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |
| 3 | A medical device with high risk that requires premarket approval | 16 |