| Primary Device ID | 00850006613267 |
| NIH Device Record Key | 3a5640f6-b499-4d15-88ed-c3c9472dcec2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | t:connect Mobile Application (Android) |
| Version Model Number | 1004127 |
| Company DUNS | 827900809 |
| Company Name | TANDEM DIABETES CARE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850006613267 [Primary] |
| PJT | Continuous Glucose Monitor Secondary Display |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-01-22 |
| Device Publish Date | 2019-12-18 |
| 00389152706474 - Pharmacy Kit, Starter Pack, Tandem T:slim | 2025-06-02 Tandem t:slim Starter Kit |
| 00389152707679 - Tandem t:slim Autosoft 30 kit | 2025-06-02 Tandem t:slim ASFT30 PK14 23" |
| 00389152708379 - Tandem t:slim AutoSoft XC Kit | 2025-06-02 Tandem t:slim ASFTXC PK14 23" |
| 00389152708973 - Tandem t:slim Autosoft 30 kit | 2025-06-02 Tandem tslim ASFT30 PK10 23" |
| 00389152709574 - Tandem t:slim AutoSoft XC Kit | 2025-06-02 Tandem t:slim ASFTXC PK10 23" |
| 00389152710174 - Tandem t:slimTruSteel Kit | 2025-06-02 Tandem t:slim TRUSTL PK10 23" |
| 00389152480114 - Tandem Mobi, pump, Control-IQ 7.9 | 2025-05-05 Tandem Mobi, pump, Control-IQ 7.x |
| 00389152523347 - Tandem Mobi Mobile Application | 2025-04-30 Tandem Mobi Mobile Application |