Identity
- Trade Name
- Tandem Mobi FDA UDI
- Generic Name
- Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm FDA UDI
- Device Name
- Tandem Mobi Pump with Control-IQ, Replacement FDA UDI
- Model / Reference
- 1012719 FDA UDI
- Description
- Tandem Mobi Pump with Control-IQ, Replacement FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00389152271910 FDA UDI
- 510(k) Number
- K223213 FDA UDI
- FDA Product Code
- QFG FDA UDI
- GMDN Term
- Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5730 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
Yes
Category: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Explore the Tandem Mobi portable electronic device, a comprehensive and user-friendly insulin infusion pump designed to provide continuous or intermittent subcutaneous delivery of insulin to individuals with diabetes mellitus. Its software-based design enables precise dosing and automated tracking of glucose status, ensuring optimal medication management and minimizing risk.
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Also classified as Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm.
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Cleared under the same submission
K223213 also covers:
- Tandem Mobi — Tandem Diabetes Care, Inc.
- Tandem Mobi — Tandem Diabetes Care, Inc.
- Tandem Mobi — Tandem Diabetes Care, Inc.
- Tandem Mobi — Tandem Diabetes Care, Inc.
- Tandem Mobi Cartridge — Tandem Diabetes Care, Inc.
- Tandem Mobi Cartridge — Tandem Diabetes Care, Inc.
- Tandem Mobi Cartridge — Tandem Diabetes Care, Inc.
- Tandem Mobi Starter Kit — Tandem Diabetes Care, Inc.
- Tandem Mobi Starter Kit — Tandem Diabetes Care, Inc.
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 7f728b59-d1dd-4b6d-9dba-7f69e7d04e8d 34 fields · synced Jul 25, 2026