Identity
- Trade Name
- t:slim G4 Cartridge 10 Pack FDA UDI
- Generic Name
- Ambulatory insulin infusion pump reservoir 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
- 007526 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
- 00852162004415 FDA UDI
- PMA Number
- P140015 FDA UDI
- FDA Product Code
- OYC FDA UDI
- GMDN Term
- Ambulatory insulin infusion pump reservoir FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 3 Milliliter FDA UDI
Category: Ambulatory insulin infusion pump reservoir
t:slim G4 Cartridge 10 Pack by Tandem Diabetes Care, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ambulatory insulin infusion pump reservoir.
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Cleared under the same submission
P140015 also covers:
- t:slim G4 Cartridge 2 Pack — Tandem Diabetes Care, Inc.
- t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM — Tandem Diabetes Care, Inc.
- t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM, Replacement — Tandem Diabetes Care, Inc.
- t:slim G4 Insulin Pump, Reconditioned — Tandem Diabetes Care, Inc.
- t:slim G4 Insulin Pump, Reconditioned Replacement — Tandem Diabetes Care, Inc.
- t:slim X2 5.0 Insulin Pump — Tandem Diabetes Care, Inc.
- t:slim X2 5.0 Insulin Pump — Tandem Diabetes Care, Inc.
- t:slim X2 5.0 Insulin Pump — Tandem Diabetes Care, Inc.
- t:slim X2 5.0 Insulin Pump — Tandem Diabetes Care, Inc.
- t:slim X2 5.0 Insulin Pump — Tandem Diabetes Care, Inc.
- t:slim X2 5.x Insulin Pump — Tandem Diabetes Care, Inc.
- t:slim X2 Cartridge, t:lock, 10 Pack — Tandem Diabetes Care, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tandem Diabetes Care, Inc.
Sources (1)
- FDA UDI 9c65f3c5-7085-4ba6-a06b-85e0a876ffbd 37 fields · synced Jun 8, 2026