FDA Registration
Active
🇺🇸 United States
Tandem Diabetes Care, INC.
Reg #: 3013756811
·
FEI: 3013756811
·
Expires 2026
Products
11
Proprietary Names
18
Establishment Types
5
Classifications
11
Registration Details
- Registration Name
- Tandem Diabetes Care, INC.
- Registration Number
- 3013756811
- FEI Number
- 3013756811
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10151 Barnes Canyon Road, 10151 Barnes Canyon Road
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240309
- PMA Number
- P180008
Owner / Operator
- Firm Name
- Tandem Diabetes Care, Inc.
- Operator Number
- 10039506
- Address
- 12400 High Bluff Drive
- City
- San Diego
- State
- CA
- Postal Code
- 92130
- Country
- US
- Correspondent
- Mark Tarby
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Alternate Controller Enabled Insulin Infusion Pump | QFG | Class 2 | Clinical Chemistry | No | 2024-08-19 |
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2017-04-26 |
| Sensor, Glucose, Invasive, Non-Adjunctive | PQF | Class 3 | Unknown | No | 2018-07-27 |
| Automated Insulin Dosing , Threshold Suspend | OZO | Class 3 | Unknown | No | 2018-07-27 |
| Interoperable Automated Glycemic Controller | QJI | Class 2 | Clinical Chemistry | No | 2020-11-23 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2023-12-01 |
| Interoperable Automated Glycemic Controller, Insulin Suspend | QJS | Class 2 | Clinical Chemistry | No | 2020-11-23 |
| Calculator, Drug Dose | NDC | Class 2 | Anesthesiology | No | 2020-11-23 |
| Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | OYC | Class 3 | Unknown | No | 2015-09-09 |
| Sensor, Glucose, Invasive | MDS | Class 3 | Unknown | No | 2015-09-09 |
| Accessories, Pump, Infusion | MRZ | Class 2 | General Hospital | No | 2017-04-26 |
Proprietary Names
Tandem Mobi System
t:slim X2
t:slim insulin delivery system
t:slim X2 with Basal-IQ technology
t:slim X2 with Basal-IQ
t:slim X2 Insulin Pump
t:slim X2 Insulin Pump with Basal-IQ
t:slim X2 with Control-IQ technology
Tandem Mobi Adhesive Sleeve
t:slim Insulin Delivery System
Control-IQ Technology
t:slim pump insulin delivery system
t:slim X2 with Basal-IQ Technology
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM
t:slim G4 System
T:slim X2 Insulin Pump
t:flex Insulin Delivery System
Tandem Device Updater
Establishment Types
Remanufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198