Identity
- Trade Name
- t:slim X2 Insulin Pump with Basal-IQ FDA UDI
- Generic Name
- Ambulatory insulin infusion pump/blood glucose analyser system FDA UDI
- Device Name
- t:slim X2 Insulin Pump with Basal-IQ, 6.6.x FDA UDI
- Model / Reference
- 1009636 FDA UDI
- Description
- t:slim X2 Insulin Pump with Basal-IQ, 6.6.x FDA UDI
Identifiers
- Catalog Number
- 1010004 FDA UDI
- Primary DI / UDI-DI
- 00389152000015 FDA UDI
- FDA Product Code
- QFG FDA UDIQJS FDA UDINDC FDA UDI
- GMDN Term
- Ambulatory insulin infusion pump/blood glucose analyser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5730 FDA UDI862.1356 FDA UDI868.1890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithmAmbulatory insulin infusion pump reservoirAmbulatory insulin infusion pump/blood glucose analyser systemAmbulatory insulin infusion pump/interstitial glucose monitoring system
t:slim X2 Insulin Pump with Basal-IQ by Tandem Diabetes Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ambulatory insulin infusion pump cartridge filling device, manual.
- 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 II
- 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 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 II
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tandem Diabetes Care, Inc.
Sources (1)
- FDA UDI 02a27cab-99ac-4687-8b74-376c32bbea93 36 fields · synced Jun 8, 2026