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

Sensor, glucose, invasive (MDS) (7) Automated insulin dosing device system, single hormonal control (OZP) (2) Automated insulin dosing , threshold suspend (OZO) (1) Artificial pancreas device system, single hormonal control (OZP) (1) Pump, infusion, insulin, to be used with invasive glucose sensor (OYC) (1) RETRACTOR (GAD) (1) GLUCOSE OXIDASE, GLUCOSE (CGA) (1) Artificial pancreas device system, threshold suspend (OZO) (1)

Premarket Exempt

No Yes

Clear

Medtronic Reusable Instruments - 00763000606183 Catalog Number :

Device Description : BLADE EX0921060 DOUBLE THK AND WD 17CM

Device Class : 1

Duns Number: 849626338

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

MiniMed™ 770G - 00763000640095 Catalog Number :

Device Description : KIT MMT-1890MD GOV V5.3A BLE MG

Device Class : 3

Duns Number: 849626338

Premarket Exempt : No

Product Code : OZP

Prescription Use : Yes

Device Count : 1

PARADIGM® REAL-time - 00885074419800 Catalog Number :

Device Description : PUMP MMT-722NAB PRDGM INSULIN BL EN PR

Device Class : 3

Duns Number: 849626338

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

PARADIGM® REAL-time - 00885074419824 Catalog Number :

Device Description : PUMP MMT-722NAP PRDGM INSULIN PL EN PR

Device Class : 3

Duns Number: 849626338

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 1

SOF-SENSOR ® - 20613994598404 Catalog Number :

Device Description : SENSOR MMT-7002C 10PK BSA NREFR 21L

Device Class :

Duns Number: 849626338

Premarket Exempt : No

Product Code : MDS, OYC, CGA

Prescription Use : Yes

Device Count : 10

iPro™2 - 20643169307708 Catalog Number :

Device Description : PLUG MMT-7744 IPRO CLEAN TST 5PK 27L RPL

Device Class :

Duns Number: 849626338

Premarket Exempt : No

Product Code : MDS

Prescription Use : Yes

Device Count : 5

Enlite® Sensor - 20643169646432 Catalog Number :

Device Description : SENSOR MMT-7008A ENLT PLUS 5PK 2L 1CL PR

Device Class :

Duns Number: 849626338

Premarket Exempt : No

Product Code : OZO, MDS

Prescription Use : Yes

Device Count : 5

Guardian ™ Sensor (3) - 20643169704057 Catalog Number :

Device Description : SENSOR MMT-7020A ENLITE3 5PK 2L US

Device Class :

Duns Number: 849626338

Premarket Exempt : No

Product Code : OZP, MDS

Prescription Use : Yes

Device Count : 5

Enlite ® - 20643169786725 Catalog Number :

Device Description : SENSOR MMT-7008A ENLT PLUS 5PK 2L 1CL PR

Device Class :

Duns Number: 849626338

Premarket Exempt : No

Product Code : MDS, OZO

Prescription Use : Yes

Device Count : 5

Tester - 20643169975105 Catalog Number :

Device Description : PLUG MMT-7736L TEST LOCKOUT 2PK EN

Device Class :

Duns Number: 849626338

Premarket Exempt : No

Product Code : OZP

Prescription Use : Yes

Device Count : 2

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