FDA UDI
In Commercial Distribution
🇺🇸 United States
t:connect Mobile Application, Mobile Bolus Enabled (iOS)
DI: 90850018992452
·
Model: 1007111
·
Tandem Diabetes Care, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- t:connect Mobile Application, Mobile Bolus Enabled (iOS)
- Primary DI
- 90850018992452
- Version / Model
- 1007111
- Company Name
- Tandem Diabetes Care, Inc.
- Labeler DUNS
- 827900809
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-15
- Public Version
- 3
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- bea82f52-6e54-4892-a0a3-a6aa50e548a4
Device Description
t:connect Mobile Application, Mobile Bolus Enabled, 2.x (iOS)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PJT | Continuous Glucose Monitor Secondary Display | Clinical Chemistry | 862.1350 | 2 |
| QFG | Alternate Controller Enabled Insulin Infusion Pump | Clinical Chemistry | 880.5730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64656 | Ambulatory insulin infusion pump software, data-display | A software application intended to allow a patient or caregiver to remotely extract and view data from an electronic ambulatory insulin infusion pump to support treatment monitoring; it is not intended to control pump settings. It is intended to be used on a non-medical computerized device (e.g., smartphone). | No | Active |
| 63804 | Ambulatory insulin infusion pump remote control | A portable electronic device designed to remotely control an electronic ambulatory insulin infusion pump or pump/administration unit. It consists of a wireless unit with dedicated software that interfaces with the pump (not included) to control and program pump functions and receive pump status information. It may transmit data to other platforms for recording/analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 90850018992452 | GS1 |
Customer Contacts
- Phone
- 877-801-6901
- [email protected]