FDA.reportPublic FDA data

MiniLink® REAL-Time

Primary DI
00763000164300
Brand
MiniLink® REAL-Time
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7703NA
Device description
XMTR MMT-7703NA UDI RJ BTRY RPL
Published
2018-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGLUCOSE OXIDASE, GLUCOSE
MDSSensor, glucose, invasive
OYCPump, infusion, insulin, to be used with invasive glucose sensor
OZOAutomated insulin dosing , threshold suspend

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
MDSSensor, Glucose, InvasiveUnknown3
OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose SensorUnknown3
OZOAutomated Insulin Dosing , Threshold SuspendUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120010108

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120010108MINIMED 530G SYSTEMMedtronic, Inc.2013-09-26OZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000164300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000164300007630001643007630001643000763000164300

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 Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 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
Serial number
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
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MHC18073002EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
00311917064635WalgreensWALGREEN CO.CGA2025-06-20
00353885013000OneTouch UltraLifeScan U.S. LLCCGA2025-06-20
00194346219254ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00194346219261ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
00054749005710i-STAT G CartridgeABBOTT POINT OF CARE INC.CGA2024-04-30
00381932488013Assy Vial, eGLU, 13 ct.POLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-07-30
MHC19902833042Members MarkWAL-MART STORES, INC.CGA2023-05-10
MHC19902833062Members MarkWAL-MART STORES, INC.CGA2023-04-18
MHC19902833072Members MarkWAL-MART STORES, INC.CGA2023-04-18
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
00353885012652OneTouch Ultra Blue Test StripsLifeScan U.S. LLCCGA2022-07-28
20763000516233Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-06-03
MHC18490502BluLinkMHC MEDICAL PRODUCTS, LLCCGA2021-05-12
20763000455662Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-05
20763000455686Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-05
20763000455655Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-04
10888277409187MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-11
10888277409170MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-10
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11
08809301160862Pip Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2020-09-11
20763000337005Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2020-07-10
20763000337005Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.OZO2020-07-10
10054749005519i-STATABBOTT POINT OF CARE INC.CGA2020-05-01
00024291121831On Call Express Blood Glucose Monitoring SystemNAVAJO MANUFACTURING COMPANYCGA2020-03-30