Identity
- Trade Name
- t:slim X2 5.0 Insulin Pump FDA UDI
- Generic Name
- Ambulatory insulin infusion pump/blood glucose analyser system FDA UDI
- Device Name
- t:slim X2 5.0 Insulin Pump, Replacement FDA UDI
- Model / Reference
- 1003487 FDA UDI
- Description
- t:slim X2 5.0 Insulin Pump, Replacement FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853052007967 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
MR Unsafe FDA UDI
Category: Ambulatory insulin infusion pump/blood glucose analyser system
t:slim X2 5.0 Insulin Pump 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.
- Omnipod — Insulet Corporation · Class II
- t:slim G4 Insulin Pump, Reconditioned Replacement — Tandem Diabetes Care, Inc. · Class III
- t:slim X2 5.x Insulin Pump — Tandem Diabetes Care, Inc. · Class III
- t:slim X2 Insulin Pump with Basal-IQ — Tandem Diabetes Care, Inc. · Class II
- t:slim X2 Insulin Pump with Control-IQ — Tandem Diabetes Care, Inc. · Class II
- t:slim X2 Insulin Pump with Control-IQ — Tandem Diabetes Care, Inc. · Class II
- t:slim X2 Insulin Pump with Basal-IQ — Tandem Diabetes Care, Inc. · Class III
- t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM — Tandem Diabetes Care, Inc. · Class III
Cleared under the same submission
P140015 also covers:
- t:slim G4 Cartridge 10 Pack — Tandem Diabetes Care, Inc.
- 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.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 |
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Manufacturer
- Manufacturer
- Tandem Diabetes Care, Inc.
Sources (1)
- FDA UDI 0ecf9c57-c1f0-4a03-8f34-91b3d61fca93 36 fields · synced Jun 8, 2026