Primary Device ID | 00389152000947 |
NIH Device Record Key | 96d58e80-9b11-4df5-89b0-2bcc8817ec6c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tandem Mobi Cartridge |
Version Model Number | 1007780 |
Company DUNS | 827900809 |
Company Name | Tandem Diabetes Care, Inc. |
Device Count | 2 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 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 | 00389152000947 [Unit of Use] |
GS1 | 00389152773759 [Primary] |
GS1 | 00389152778051 [Primary] |
QFG | Alternate Controller Enabled Insulin Infusion Pump |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-07 |
Device Publish Date | 2023-10-30 |
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 |