FDA.reportPublic FDA data

1-Press Serter

Primary DI
00643169761810
Brand
1-Press Serter
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7512NA
Device description
SERTER MMT-7512NA ENLITE 1CLK US
Published
2016-07-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZOArtificial pancreas device system, threshold suspend

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZOAutomated Insulin Dosing , Threshold SuspendUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120010070

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120010070MINIMED 530G SYSTEMMedtronic, Inc.2013-09-26OZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169761810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169761810006431697618106431697618100643169761810

GMDN Terms#

Term, Definition table
TermDefinition
Injector reset deviceA device designed to be used by a layperson (this usually being the recipient of the injection) to reset the loaded position of an injector in a safe and controlled manner. It will typically be designed like a small box or container and have a hinged lid. The injector is placed inside this device and when the lid is closed an internal mechanism resets the injector to its firing position. The injector is removed from this device, the medication is inserted (typically a prefilled syringe or cartridge) and it is ready for use by the user. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
849626338
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150002375MiniMed AppMMT-80982026-05-25
00199150002382MiniMed AppMMT-80992026-05-25
00199150077380MiniMed FlexMMT-80622026-05-25
00199150021031MiniMed FlexMMT-80702026-05-24
00763000848149MiniMed FlexMMT-80622026-05-21
00763000848156MiniMed FlexMMT-80722026-05-21
00763000990695INFINITY™ Occipitocervical Upper Thoracic System36503152026-03-22
20763000519692Guardian™ 4 SensorMMT-7040MA2023-05-06
20763000413389Guardian™ 4 SensorMMT-7040A2023-05-06
00763000413477Guardian™ 4 SensorMMT-7040B2023-05-05
20763000519685Guardian™ 4 SensorMMT-7040PA2023-05-06
20763000273358MiniMed™ ReservoirMMT-332A2019-09-02
00199150047000MiniMed 780G Insulin PumpMMT-18842025-11-08
00199150047024MiniMed 780G Insulin PumpMMT-18842025-11-08
00199150047048MiniMed 780G Insulin pumpMMT-18942025-11-08
00199150047055MiniMed 780G Insulin PumpMMT-1894MD2025-11-08
00199150034123SFTWR MMT-6101 AHCL APP 3.1 ANDROIDMMT-61012025-09-26
00199150034130MiniMed Mobile AppMMT-61022025-09-26
00613994757197iPro™2MMT-77412014-09-25
00613994951274iPro™2MMT-77422014-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169455535ENLiTE™MEDTRONIC MINIMED, INC.OZO2023-07-20
00763000391041Guardian™ Link (3)MEDTRONIC XOMED, INC.OZO2020-10-26
00763000391065Guardian™ Link (3)MEDTRONIC MINIMED, INC.OZO2020-10-26
00763000389024Guardian ™ Link (3)MEDTRONIC XOMED, INC.OZO2020-09-06
00763000400620Guardian™ Link (3)MEDTRONIC MINIMED, INC.OZO2020-09-06
00763000337049Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.OZO2020-07-11
20763000337005Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.OZO2020-07-10
00763000337001Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.OZO2020-07-10
00763000395858MiniMed® 670GMEDTRONIC MINIMED, INC.OZO2020-07-06
00763000367091MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2020-05-18
00763000341923One-press SerterMEDTRONIC MINIMED, INC.OZO2020-05-16
00763000367053MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2020-05-16
00763000367060MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2020-05-16
00850006613373t:slim X2 Insulin Pump with Basal-IQTandem Diabetes Care, Inc.OZO2020-02-04
00850006613380t:slim X2 Insulin Pump with Basal-IQTandem Diabetes Care, Inc.OZO2020-02-04
00763000317591MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000317607MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000317614MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000317621MiniMed™ 630GMEDTRONIC MINIMED, INC.OZO2019-11-15
00763000316631MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316648MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316655MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316662MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316679MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
00763000316686MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-10-27
10301937550154CONTOUR®NEXTASCENSIA DIABETES CARE US INC.OZO2019-08-30
00763000283445MiniMed® 670GMEDTRONIC MINIMED, INC.OZO2019-08-29
00763000256807MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-05-25
00763000256814MiniMed® 630GMEDTRONIC MINIMED, INC.OZO2019-05-25
00763000256838MiniMed® 670GMEDTRONIC MINIMED, INC.OZO2019-05-25