MEDTRONIC, INC.

Address:8200 Coral Sea Street NE,Mounds View,MN,55112,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

Filter, blood, cardiopulmonary bypass, arterial line (DTM) (3) HEAT-EXCHANGER, CARDIOPULMONARY BYPASS (DTR) (2) OXYGENATOR, CARDIOPULMONARY BYPASS (DTZ) (2) STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR (MHY) (1) TUBING, PUMP, CARDIOPULMONARY BYPASS (DWE) (1) CATHETER, PERCUTANEOUS (DQY) (1) implanted subcortical electrical Stimulator (motor disorders) (MRU) (1) Deep brain stimulator for obsessive compulsive disorder (OCD) (OLM) (1) STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS (NHL) (1)

Premarket Exempt

No Yes

Clear

ECMOtherm- II™ - 00613994008701 Catalog Number :

Device Description : EXCHANGER 61399400870 12CA EMOTRMII HT

Device Class : 2

Duns Number: 006261481

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

ECMO - 00613994008893 Catalog Number :

Device Description : OXYGENATOR 61399400889 6PK 0800 ECMO

Device Class : 2

Duns Number: 006261481

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

ECMO - 00613994008916 Catalog Number :

Device Description : OXYGENATOR 61399400891 6CA 1500 ECMO

Device Class : 2

Duns Number: 006261481

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

BIOtherm™ - 00613994009647 Catalog Number :

Device Description : EXCHANGER 61399400964 12CA HT BIOTHERM

Device Class : 2

Duns Number: 006261481

Premarket Exempt : No

Product Code : DTR

Prescription Use : Yes

Device Count : 1

AFFINITY® - 00613994011244 Catalog Number :

Device Description : FILTER 61399401124 AFFINITY 6CA ART 351

Device Class : 2

Duns Number: 006261481

Premarket Exempt : No

Product Code : DTM

Prescription Use : Yes

Device Count : 1

AFFINITY® - 00613994011534 Catalog Number :

Device Description : FILTER 61399401153 AFFINITY 6CA ART 352

Device Class : 2

Duns Number: 006261481

Premarket Exempt : No

Product Code : DTM

Prescription Use : Yes

Device Count : 1

AFFINITY® - 00613994094346 Catalog Number :

Device Description : FILTER 61399409434 AFFINITY 6CA ARFIL20M

Device Class : 2

Duns Number: 006261481

Premarket Exempt : No

Product Code : DTM

Prescription Use : Yes

Device Count : 1

SHERPA NX BALANCED - 00613994096593 Catalog Number :

Device Description : CATHETER SB8JR40 SB 8F 100CM JR40

Device Class : 2

Duns Number: 006261481

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

NA - 00613994097408 Catalog Number :

Device Description : CUSTOM PACK 4L43R 4PK CUSTOM Y

Device Class : 2

Duns Number: 006261481

Premarket Exempt : No

Product Code : DWE

Prescription Use : Yes

Device Count : 1

ACTIVA® Therapy - 00613994099068 Catalog Number :

Device Description : EXTN KIT 7482A40 QD LOW IMP/PRFL 40CM AA

Device Class : 3

Duns Number: 796986144

Premarket Exempt : No

Product Code : NHL, MHY, OLM, MRU

Prescription Use : Yes

Device Count : 1

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