FDA.reportPublic FDA data

Tester

Primary DI
20643169975105
Brand
Tester
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7736L
Device description
PLUG MMT-7736L TEST LOCKOUT 2PK EN
Published
2019-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZPAutomated insulin dosing device system, single hormonal control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZPAutomated Insulin Dosing Device System, Single Hormonal ControlUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160017003

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160017003MiniMed 670G SystemMedtronic Minimed, Inc.2016-09-28OZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20643169975105PrimaryGS10
00643169975101Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2064316997510520643169975105
00643169975101006431699751016431699751010643169975101

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous glucose monitoring systemAn assembly of portable, battery-powered devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive technique. It consists of a sterile, electrochemical, percutaneously-inserted electrode that connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home or clinical setting, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius5 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
2
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
00199150047000MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.OZP2025-11-08
00199150047024MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.OZP2025-11-08
00199150003686MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
00763000960018MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
00763000960025MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
00763000960049MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-19
20763000956381Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956400Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956417Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956394Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
20763000956404Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
20763000956411Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000960032MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2025-06-01
00763000956387Simplera Sync™MEDTRONIC MINIMED, INC.OZP2025-06-01
00763000926106MiniMed™ 770GMEDTRONIC MINIMED, INC.OZP2024-07-01
00763000926113MiniMed™ 770GMEDTRONIC MINIMED, INC.OZP2024-07-01
00763000924089MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-06-08
00763000924096MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-06-08
00763000924102MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-06-08
00763000924119MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-06-08
00763000910082MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2024-02-03
00763000865665MiniMed™ 780GMEDTRONIC MINIMED, INC.OZP2023-10-01
00365702702882ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-21
00365702702417ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-21
10365702702889ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-21
00365702702479ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-06
00365702702530ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-06
10365702702476ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-06
10365702702537ACCU-CHEK GUIDE LINKRoche Diagnostics Operations, Inc.OZP2023-09-06
00763000859206One-press SerterMEDTRONIC MINIMED, INC.OZP2023-08-27