Primary Device ID | 20763000956411 |
NIH Device Record Key | 2300df8e-e3db-458a-ad96-23f79fda51d5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Simplera Sync™ |
Version Model Number | MMT-5120MA |
Company DUNS | 849626338 |
Company Name | MEDTRONIC MINIMED, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
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 | true |
OTC Over-The-Counter | false |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000956417 [Primary] |
GS1 | 20763000956411 [Package] Contains: 00763000956417 Package: PK [5 Units] In Commercial Distribution |
OZP | Automated insulin dosing device system, single hormonal control |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-09 |
Device Publish Date | 2025-06-01 |
00763000956387 | SENSOR MMT-5120A SIMPLERA SYNC 5PK US |
20763000956411 | SENSOR MMT-5120MA SIM SYNC 5PK MED US |
20763000956404 | SENSOR MMT-5120PA SIM SYNC 5PK PHARMA US |
00763000956394 | SENSOR MMT-5120B SIMPLERA SYNC 1PK US |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SIMPLERA SYNC 98254152 not registered Live/Pending |
Medtronic MiniMed, Inc 2023-11-03 |