Primary Device ID | 00389152000961 |
NIH Device Record Key | cf950fc4-c497-4615-8600-a751316afac0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tandem Mobi Adhesive Sleeve |
Version Model Number | 1010123 |
Company DUNS | 827900809 |
Company Name | Tandem Diabetes Care, Inc. |
Device Count | 10 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
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 | 00389152000961 [Unit of Use] |
GS1 | 00389152076157 [Primary] |
KGX | Tape And Bandage, Adhesive |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-13 |
Device Publish Date | 2023-12-05 |
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 |