One-press Serter

GUDID 00643169980525

SERTER MMT-7512N 1CLK GENERIC 2L

MEDTRONIC MINIMED, INC.

Injector reset device
Primary Device ID00643169980525
NIH Device Record Key9c3163cb-f4be-4352-bd5e-7b1e664e0c17
Commercial Distribution StatusIn Commercial Distribution
Brand NameOne-press Serter
Version Model NumberMMT-7512N
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 HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169980525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZPArtificial pancreas device system, single hormonal control

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 Date2017-10-30

On-Brand Devices [One-press Serter]

00643169980525SERTER MMT-7512N 1CLK GENERIC 2L
00763000341930SERTER MMT-7512NA IIN 1CLK US
00763000341923SERTER MMT-7512N IIN GENERIC 2L
00763000859206SERTER MMT-7512G IIN 1CLK G4S US 3L

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