MEDTRONIC MINIMED, INC.

Address:18000 Devonshire St,NORTHRIDGE,CA,91325,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Automated insulin dosing device system, single hormonal control (OZP) (4) Insulin pump secondary display (PKU) (4) Sensor, glucose, invasive (MDS) (2) INTRODUCER, SYRINGE NEEDLE (KZH) (1)

Premarket Exempt

No Yes

Clear

Guardian™ Sensor (3) - 00763000455675 Catalog Number :

Device Description : SENSOR MMT-7020B GS3 1PK 2L US

Device Class : 3

Duns Number: 849626338

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

CareLink™ Connect - 00763000480646 Catalog Number :

Device Description : SFTWR MMT-6113 CL CONN CLIN ANDRD 2.1.1

Device Class : 2

Duns Number: 849626338

Premarket Exempt : Yes

Product Code : PKU

Prescription Use : No

Device Count : 1

CareLink™ Connect - 00763000480653 Catalog Number :

Device Description : SFTWR MMT-6114 CL CONN CLIN IOS 2.1.1

Device Class : 2

Duns Number: 849626338

Premarket Exempt : Yes

Product Code : PKU

Prescription Use : No

Device Count : 1

MiniMed™ Mobile - 00763000480660 Catalog Number :

Device Description : SFTWR MMT-6103 MM MBL CLIN ANDRD 1.0.0

Device Class : 2

Duns Number: 849626338

Premarket Exempt : Yes

Product Code : PKU

Prescription Use : No

Device Count : 1

MiniMed™ Mobile - 00763000480677 Catalog Number :

Device Description : SFTWR MMT-6104 MM MBL CLIN IOS 1.0.0

Device Class : 2

Duns Number: 849626338

Premarket Exempt : Yes

Product Code : PKU

Prescription Use : No

Device Count : 1

Guardian™ Link (3) - 00763000521363 Catalog Number :

Device Description : KIT MMT-7910MNA ASSY GST5C US MEDICARE

Device Class : 3

Duns Number: 849626338

Premarket Exempt : No

Product Code : OZP

Prescription Use : Yes

Device Count : 1

MiniMed™ Quick-serter™ - 00763000573690 Catalog Number :

Device Description : SERTER MMT-305QS PLUNGER BAG MDR

Device Class : 2

Duns Number: 849626338

Premarket Exempt : No

Product Code : KZH

Prescription Use : Yes

Device Count : 1

Guardian™ Sensor (3) - 00763000578794 Catalog Number :

Device Description : SENSOR MMT-7020A GS3 5PK US

Device Class : 3

Duns Number: 849626338

Premarket Exempt : No

Product Code : MDS, OZP

Prescription Use : Yes

Device Count : 1

MiniMed™ 770G - 00763000586188 Catalog Number :

Device Description : PUMP MMT-1880 MM770G V5.3A BLE MG

Device Class : 3

Duns Number: 849626338

Premarket Exempt : No

Product Code : OZP

Prescription Use : Yes

Device Count : 1

MiniMed™ 770G - 00763000586195 Catalog Number :

Device Description : PUMP MMT-1880L MM770G V5.3A BLE MG

Device Class : 3

Duns Number: 849626338

Premarket Exempt : No

Product Code : OZP

Prescription Use : Yes

Device Count : 1

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