FDA.reportPublic FDA data

CareLink®

Primary DI
00613994342805
Brand
CareLink®
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7335
Device description
SOFTWARE MMT-7335 CD-ROM CARELINK PRO EN
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDSSensor, glucose, invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDSSensor, Glucose, InvasiveUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980022034

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980022034CONTINUOUS GLUCOSE MONITORING SYSTEMMedtronic Minimed1999-06-15MDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994342805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994342805006139943428056139943428050613994342805

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.

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
00763000578848Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2022-11-26
00763000578794Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2022-01-02
20763000578798Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2022-01-02
20763000516233Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-06-03
00763000516239Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-06-03
20763000455662Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-05
20763000455686Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-05
00763000455675Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-05
00763000455668Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-05
00763000455682Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-05
20763000455655Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-04
00763000455651Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2021-04-04
00763000348021TesterMEDTRONIC MINIMED, INC.MDS2021-03-28
00763000423124Paradigm® REAL-TimeMEDTRONIC MINIMED, INC.MDS2020-11-15
00763000423131Paradigm® REAL-Time Revel™MEDTRONIC MINIMED, INC.MDS2020-11-15
00763000388355Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2020-11-09
00763000388379Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2020-10-26
00763000408886Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2020-08-03
00763000408893Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2020-08-03
00763000381097Guardian™ Connect AppMEDTRONIC MINIMED, INC.MDS2020-08-02
00763000381103Guardian™ Connect AppMEDTRONIC MINIMED, INC.MDS2020-08-02
00763000337049Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2020-07-11
20763000337005Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2020-07-10
00763000399009Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2020-07-02
00763000398330Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2020-06-19
00763000341923One-press SerterMEDTRONIC MINIMED, INC.MDS2020-05-16
00763000285852Guardian™ ConnectMEDTRONIC MINIMED, INC.MDS2019-08-29
00763000179601Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2019-06-23
00763000179625Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2019-06-22
20763000179629Guardian™ Sensor (3)MEDTRONIC MINIMED, INC.MDS2019-06-22