Simplera Sync™

GUDID 00763000956387

SENSOR MMT-5120A SIMPLERA SYNC 5PK US

MEDTRONIC MINIMED, INC.

Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Primary Device ID00763000956387
NIH Device Record Key12e17267-a88b-4e6c-a84f-e1a8e3af80dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimplera Sync™
Version Model NumberMMT-5120A
Company DUNS849626338
Company NameMEDTRONIC MINIMED, INC.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000956387 [Unit of Use]
GS120763000956381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZPAutomated insulin dosing device system, single hormonal control

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-09
Device Publish Date2025-06-01

On-Brand Devices [Simplera Sync™]

00763000956387SENSOR MMT-5120A SIMPLERA SYNC 5PK US
20763000956411SENSOR MMT-5120MA SIM SYNC 5PK MED US
20763000956404SENSOR MMT-5120PA SIM SYNC 5PK PHARMA US
00763000956394SENSOR MMT-5120B SIMPLERA SYNC 1PK US

Trademark Results [Simplera Sync]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIMPLERA SYNC
SIMPLERA SYNC
98254152 not registered Live/Pending
Medtronic MiniMed, Inc
2023-11-03

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