Medtronic Guardian™ Link

Primary DI
00643169283183
Brand
Medtronic Guardian™ Link
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7715
Device description
CHARGER MMT-7715 MLNK GST3 21L RPL
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGLUCOSE OXIDASE, GLUCOSE
MDSSensor, glucose, invasive
OYCPump, infusion, insulin, to be used with invasive glucose sensor
OZOArtificial pancreas device system, 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
P150001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150001000MINIMED 630G SYSTEM WITH SMARTGUARD(TM)Medtronic Minimed2016-08-10OZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169283183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169283183006431692831836431692831830643169283183

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous interstitial fluid glucose monitoring system, electrochemicalAn assembly of electrically-powered, portable devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically 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 and clinical settings, 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 Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
849626338
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000974589InPenMMT-80602025-04-29
00763000974596InPenMMT-80612025-04-29
00763000489953InPen Smart Insulin Delivery SystemMMT-80602025-03-08
00763000489960InPen Smart Insulin Delivery SystemMMT-80612025-03-08
00763000827182inpen™MMT-105NNBLNA2024-06-03
00763000827199inpen™MMT-105NNGYNA2024-06-03
00763000827205inpen™MMT-105NNPKNA2024-06-03
00763000827151inpen™MMT-105ELBLNA2024-05-31
00763000827168inpen™MMT-105ELGYNA2024-05-31
00763000827175inpen™MMT-105ELPKNA2024-06-02
00763000924089MiniMed™ 780GMMT-18842024-06-08
00199150001231App ManagerMMT-8097M2026-06-18
00199150038978MiniMed GoMMT-86002026-06-14
00199150038985MiniMed GoMMT-86012026-06-14
20763000336985Guardian™ Sensor (3)MMT-7020LA2020-10-12
20763000337005Guardian™ Sensor (3)MMT-7020A2020-07-10
20763000358444Guardian™ Sensor (3)MMT-7020PLA2020-10-31
20763000455655Guardian™ Sensor (3)MMT-7020GA2021-04-04
20763000455662Guardian™ Sensor (3)MMT-7020A2021-04-05
20763000455686Guardian™ Sensor (3)MMT-7020PLA2021-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613994141385PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994141422PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994141507PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994141521PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994141590PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994141606PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994141637PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994141651PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.OYC2014-09-24
00613994141651PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994176851GUARDIAN®MEDTRONIC MINIMED, INC.MDS2014-09-24
00613994202147PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994202154PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994202161PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994202178PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994202185PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994202192PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994202208PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994202215PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994223678PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994223685PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994223692PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994223708PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994223715PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994223722PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994223739PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994223746PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994224422PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994224439PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994224446PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24
00613994224453PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.MDS2014-09-24