Primary Device ID | 00850006613274 |
NIH Device Record Key | 9c9fe4e3-4fa2-42a8-b853-b79070a465f8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | t:connect Mobile Application (iOS) |
Version Model Number | 1004128 |
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 | 00850006613274 [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 |