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t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM

FDA UDI

Class III (US FDA UDI)

by Tandem Diabetes Care, Inc.

Identity

Trade Name
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM FDA UDI
Generic Name
Ambulatory insulin infusion pump/blood glucose analyser system FDA UDI
Device Name
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. FDA UDI
Model / Reference
006194 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00852162004408 FDA UDI
PMA Number
P140015 FDA UDI
FDA Product Code
OYC FDA UDI
GMDN Term
Ambulatory insulin infusion pump/blood glucose analyser system FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Ambulatory insulin infusion pump/blood glucose analyser system

t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM by Tandem Diabetes Care, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory insulin infusion pump/blood glucose analyser system.

Cleared under the same submission

P140015 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tandem Diabetes Care, Inc.

Sources (1)

  • FDA UDI 88428bbf-16ac-418d-b123-45d0e686a814 36 fields · synced Jun 8, 2026