1-Press Serter

GUDID 00643169761810

SERTER MMT-7512NA ENLITE 1CLK US

MEDTRONIC MINIMED, INC.

Injector reset device
Primary Device ID00643169761810
NIH Device Record Keyba51effb-a8c1-42df-bb63-57ec254cdd8d
Commercial Distribution StatusIn Commercial Distribution
Brand Name1-Press Serter
Version Model NumberMMT-7512NA
Company DUNS849626338
Company NameMEDTRONIC MINIMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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 -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169761810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZOArtificial pancreas device system, threshold suspend

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-30

Devices Manufactured by MEDTRONIC MINIMED, INC.

00199150003686 - MiniMed™ 780G2025-06-27 PUMP MMT-1884G 780G 6.21 GS
00763000960018 - MiniMed™ 780G2025-06-27 Kit MMT-1894 780G US A2.01 6.42U
00763000960025 - MiniMed™ 780G2025-06-27 KIT MMT-1894MD 780G US GOV 6.42U A2.01 S
00763000960049 - MiniMed™ 780G2025-06-27 PUMP MMT-1884 780G US MG A2.01 6.41U PRB
00763000956394 - Simplera Sync™2025-06-09 SENSOR MMT-5120B SIMPLERA SYNC 1PK US
20763000956404 - Simplera Sync™2025-06-09 SENSOR MMT-5120PA SIM SYNC 5PK PHARMA US
20763000956411 - Simplera Sync™2025-06-09 SENSOR MMT-5120MA SIM SYNC 5PK MED US
00763000960032 - MiniMed™ 780G2025-06-09 Pump MMT-1884 780G US A2.01 6.42U

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.