Identity
- Trade Name
- t:connect Mobile Application (iOS) FDA UDI
- Generic Name
- Ambulatory insulin infusion pump software, data-display FDA UDI
- Device Name
- t:connect Mobile Application (iOS) FDA UDI
- Model / Reference
- 1004128 FDA UDI
- Description
- t:connect Mobile Application (iOS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850006613274 FDA UDI
- FDA Product Code
- PJT FDA UDI
- GMDN Term
- Ambulatory insulin infusion pump software, data-display FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1350 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ambulatory insulin infusion pump software, data-display
t:connect Mobile Application (iOS) by Tandem Diabetes Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- t:connect Mobile Application (Android) — Tandem Diabetes Care, Inc. · Class II
- t:connect Mobile Application, Mobile Bolus Enabled (Android) — Tandem Diabetes Care, Inc. · Class II
- t:connect Mobile Application, Mobile Bolus Enabled (iOS) — Tandem Diabetes Care, Inc. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Tandem Diabetes Care, Inc.
Sources (1)
- FDA UDI 9c9fe4e3-4fa2-42a8-b853-b79070a465f8 34 fields · synced Jun 8, 2026