Med Michigan Holdings, LLC

Address:2140 Oak Industrial Drive NE,Grand Rapids,MI,49505,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

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (6) Clamp, Surgical, General & Plastic Surgery (GDJ) (4)

Premarket Exempt

No Yes

Clear

Surge Cardiovascular - 00817278010538 Catalog Number : TOU-7903S

Device Description : Pediatric Tourniquet Kit with Snare, 1 red, 2 blue, 3 clear, 5.5" length

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010545 Catalog Number : TOU-7904S

Device Description : Adult Tourniquet Kit with Snare, 1 red, 1 blue, 7" length

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010552 Catalog Number : TOU-7905S

Device Description : Vena Caval Tourniquet Kit with Snare, 3 clear, 7" length

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010569 Catalog Number : TOU-7906S

Device Description : Complete Adult Tourniquet Kit with Snare, 1 red, 1 blue, 3 clear, 7" length

Device Class : 1

Duns Number: 097462979

Premarket Exempt : Yes

Product Code : GDJ

Prescription Use : No

Device Count : 1

Surge Cardiovascular - 00817278010682 Catalog Number : ANT-1012S

Device Description : Antegrade Cardioplegia Cannula, 12Ga (9Fr), with Insertion Needle, 14Ga

Device Class :

Duns Number: 097462979

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010699 Catalog Number : RMH-T015S

Device Description : Retrograde Cardioplegia Cannula, Manual Inflate Text.Balloon Stopcock Rigid Styl

Device Class : 2

Duns Number: 097462979

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010705 Catalog Number : RMN-T015S

Device Description : Retrograde Cardioplegia Cannula, Manually Inflating Textured Balloon, Stopcock,

Device Class : 2

Duns Number: 097462979

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278010712 Catalog Number : RSG-T014S-L

Device Description : Retrograde Cardioplegia Cannula, Self-Inflating text med balloon, Guidewire styl

Device Class : 2

Duns Number: 097462979

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Terumo Cardiovascular Systems - 00817278010729 Catalog Number : 824364

Device Description : Vented Adapter

Device Class : 2

Duns Number: 097462979

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Terumo Cardiovascular Systems - 00817278010736 Catalog Number : 824365

Device Description : Recirculation Adapter

Device Class : 2

Duns Number: 097462979

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

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