| Primary Device ID | 00389152480114 |
| NIH Device Record Key | b31e8b84-310b-4c38-9652-c0c59eb757c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tandem Mobi, pump, Control-IQ 7.9 |
| Version Model Number | 1014801 |
| Company DUNS | 827900809 |
| Company Name | Tandem Diabetes Care, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00389152480114 [Primary] |
| QFG | Alternate Controller Enabled Insulin Infusion Pump |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-05 |
| Device Publish Date | 2025-04-25 |
| 00389152547244 - Tandem Mobi Mobile Application, Android | 2025-12-24 Tandem Mobi Mobile Application, Android |
| 00389152858173 - Tandem t:slim Autosoft 30 Kit | 2025-12-22 AutoSoft 30, 23"13 mm 10 Pack |
| 00389152858777 - Tandem t:slim Autosoft XC Kit | 2025-12-22 AutoSoft XC, 23"/6 mm 10 Pack |
| 00389152859477 - Tandem t:slimTruSteel Kit | 2025-12-22 TruSteel, 23"/6 mm 10 Pack |
| 00389152852379 - Tandem Mobi Autosoft XC Kit | 2025-12-18 AutoSoft XC, 5"/6mm 10 Pack |
| 00389152852973 - Tandem Mobi Autosoft XC Kit | 2025-12-18 AutoSoft XC, 23"/6mm 10 Pack |
| 00389152853772 - Tandem Mobi Autosoft 30 Kit | 2025-12-18 AutoSoft 30, 23"/13mm 10 Pack |
| 00389152854373 - Tandem Mobi TruSteel Kit | 2025-12-18 TruSteel, 23"/6mm 10 Pack |