Primary Device ID | 00389152106113 |
NIH Device Record Key | a9ffc0e9-45d1-4c92-a751-f6c65331eb4d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tandem Source |
Version Model Number | 1011061 |
Catalog Number | 1011061 |
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 | 00389152106113 [Primary] |
PHV | Continuous Glucose Monitor Retrospective Data Analysis Software |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-28 |
Device Publish Date | 2023-06-20 |
00389152311777 - Tandem Mobi Starter Kit | 2024-04-04 with Control-IQ 7.X |
00389152311876 - Tandem Mobi Autosoft XC Kit | 2024-03-29 Autosoft XC, 5"/6mm, 2 pack kit |
00389152311975 - Tandem Mobi Autosoft XC Kit | 2024-03-29 Autosoft XC, 5"/6mm, 2 pack kit |
00389152312071 - Tandem Mobi Autosoft XC Kit | 2024-03-29 Autosoft XC 23"/6mm 10 pack |
00389152312170 - Tandem Mobi Autosoft 30 Kit | 2024-03-29 Autosoft 30, 23"/13mm, 10 pack kit |
00389152312279 - Tandem Mobi TruSteel Kit | 2024-03-29 TruSteel, 23"/6mm, 10 pack kit |
00389152319513 - t:slim X2 Insulin Pump with Control-IQ Technology | 2023-12-14 Control-IQ 7.8 |
00389152319612 - t:slim X2 Insulin Pump with Control-IQ Technology | 2023-12-14 Control-IQ 7.8 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TANDEM SOURCE 90398407 not registered Live/Pending |
Tandem Diabetes Care, Inc. 2020-12-21 |